# PRODUCT RECALL & ADVERSE EVENT REPORTING POLICY
## 1. INTRODUCTION
This Product Recall & Adverse Event Reporting Policy ("Policy") applies to all products sold, supplied, distributed, exported, imported, marketed, or otherwise made available through [www.surgestore.in](http://www.surgestore.in) ("Website"), operated by Jindal Medi Surge ("JMS", "Company", "we", "our", "us").
This Policy establishes procedures and responsibilities relating to:
* Product recalls
* Field Safety Corrective Actions (FSCA)
* Field Safety Notices (FSN)
* Safety alerts
* Adverse event reporting
* Product complaints
* Product traceability
* Post-market surveillance activities
This Policy should be read together with the Company's:
* Terms & Conditions
* Medical Device Disclaimer
* Refund & Return Policy
* Shipping & Delivery Policy
* International Sales & Export Compliance Policy
* Privacy Policy
* Any other applicable Website policies
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# 2. PURPOSE
The purpose of this Policy is to:
* Promote patient safety
* Support regulatory compliance
* Facilitate product traceability
* Enable timely recall management
* Encourage reporting of product-related incidents
* Support corrective and preventive actions
Nothing in this Policy shall be interpreted as an admission of liability, fault, negligence, defect, warranty obligation, or regulatory non-compliance by the Company.
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# 3. DEFINITIONS
## Adverse Event
An adverse event may include any undesirable incident associated with a product, including but not limited to:
* Patient injury
* Serious deterioration in health
* Device malfunction
* Device failure
* Device breakage
* Unexpected clinical outcome
* Incorrect labeling
* Sterility concerns
* Packaging integrity issues
* User safety concerns
* Death
---
## Product Recall
A recall means any action intended to:
* Remove a product from the market
* Recover a product from customers
* Correct a product issue
* Prevent future harm
initiated by:
* Jindal Medi Surge
* Product manufacturers
* Regulatory authorities
* Competent government agencies
---
## Product Complaint
Any communication alleging deficiencies related to:
* Quality
* Performance
* Durability
* Reliability
* Labeling
* Packaging
* Safety
* Regulatory compliance
of a product.
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# 4. WHO SHOULD REPORT
Reports may be submitted by:
* Patients
* Caregivers
* Doctors
* Surgeons
* Healthcare professionals
* Hospitals
* Clinics
* Distributors
* Dealers
* Importers
* Regulatory authorities
* Other users
---
# 5. REPORTABLE EVENTS
Users should promptly report incidents involving:
### Product Malfunction
Including:
* Mechanical failure
* Structural failure
* Electrical failure
* Software failure
* Battery failure
---
### Product Breakage
Including:
* Implant fracture
* Instrument breakage
* Component separation
* Material failure
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### Packaging Concerns
Including:
* Broken seals
* Damaged sterile barriers
* Missing labeling
* Incorrect labeling
---
### Safety Concerns
Including:
* Unexpected injuries
* Device-related complications
* Safety hazards
* Potential patient risks
---
### Serious Events
Including:
* Hospitalization
* Permanent impairment
* Life-threatening situations
* Death
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# 6. REPORTING PROCEDURE
Users should submit reports as soon as reasonably possible after becoming aware of an event.
Reports should include where available:
* Product name
* Product code
* Lot number
* Batch number
* Serial number
* Date of purchase
* Date of event
* Description of incident
* Photographs
* Supporting documentation
Providing complete information assists investigation efforts.
The Company may request additional information during investigations.
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# 8. PRODUCT TRACEABILITY
To support patient safety and regulatory compliance, the Company may maintain records relating to:
* Product identifiers
* Batch numbers
* Lot numbers
* Shipment information
* Customer information
* Distribution records
Such information may be used for:
* Product recalls
* Safety notices
* Regulatory reporting
* Adverse event investigations
* Corrective actions
in accordance with applicable laws and the Privacy Policy.
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# 9. PRODUCT INVESTIGATION
Upon receiving a complaint or adverse event report, the Company may:
* Review available information
* Contact the reporting party
* Request additional documentation
* Request return of product samples
* Consult manufacturers
* Conduct technical evaluations
* Notify regulatory authorities where required
The Company reserves sole discretion regarding investigation procedures.
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# 10. PRODUCT RETURN FOR INVESTIGATION
Where necessary, customers may be requested to return products for analysis.
Return of products for investigation:
* Does not guarantee replacement
* Does not guarantee refund
* Does not constitute admission of fault
* Does not establish product defect
Returned products may be retained for technical evaluation.
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# 11. PRODUCT RECALLS
The Company may initiate or participate in recalls when required by:
* Regulatory authorities
* Manufacturers
* Safety assessments
* Quality investigations
Recall actions may include:
* Product return
* Product replacement
* Product correction
* Safety notifications
* Field corrective actions
The specific recall strategy shall be determined based on applicable circumstances.
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# 12. CUSTOMER RESPONSIBILITIES DURING RECALLS
Customers agree to:
* Maintain accurate contact information
* Monitor communications
* Follow recall instructions
* Cease product use when instructed
* Cooperate with corrective actions
* Assist in product recovery efforts
Failure to cooperate may increase risks and may limit available remedies.
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# 13. FIELD SAFETY NOTICES
The Company may issue Field Safety Notices or similar communications concerning:
* Product corrections
* Product modifications
* Updated instructions
* Safety recommendations
* Recall activities
Customers are responsible for reviewing and acting upon such notices.
---
# 14. NO GUARANTEE OF PRODUCT DEFECT
Submission of:
* Complaints
* Incident reports
* Adverse event reports
* Recall requests
does not establish that:
* A product is defective
* A product caused injury
* The Company is liable
* The manufacturer is liable
* Any legal violation occurred
All reports remain subject to investigation.
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# 15. THIRD-PARTY PRODUCTS
The Website may offer products manufactured by third parties.
For such products:
* Investigations may involve manufacturers.
* Recall decisions may be controlled by manufacturers.
* Safety communications may originate from manufacturers.
The Company may rely upon information supplied by manufacturers when responding to complaints and recalls.
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# 16. REGULATORY REPORTING
Where required by applicable law, the Company may report certain events to:
* Regulatory authorities
* Competent authorities
* Government agencies
* Medical device regulators
The Company reserves discretion regarding reporting obligations as permitted by applicable law.
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# 17. DATA HANDLING
Information submitted through adverse event reports or complaints may be processed for:
* Safety investigations
* Regulatory compliance
* Product traceability
* Corrective actions
* Legal compliance
Information handling shall be governed by the Privacy Policy.
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# 18. NO MEDICAL ADVICE
Reporting an adverse event does not create:
* A doctor-patient relationship
* Medical advice
* Clinical consultation
* Healthcare services
Users should immediately seek appropriate medical care where necessary.
The Company does not provide emergency medical assistance.
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# 19. LIMITATION OF LIABILITY
To the maximum extent permitted by applicable law:
Jindal Medi Surge, its affiliates, directors, officers, employees, contractors, suppliers, distributors, agents, licensors, and representatives shall not be liable for:
* Product recalls
* Safety notices
* Investigation delays
* Regulatory actions
* Product withdrawals
* Market corrections
* Business interruptions
* Lost profits
* Lost revenue
* Lost business opportunities
* Consequential damages
* Incidental damages
* Special damages
* Punitive damages
arising from product complaints, adverse events, recalls, investigations, or corrective actions.
To the extent permitted by law, total liability shall not exceed the purchase price paid for the affected product.
Nothing in this Policy excludes liability that cannot legally be excluded under applicable law.
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# 20. CUSTOMER INDEMNIFICATION
Users agree to indemnify and hold harmless Jindal Medi Surge from claims arising from:
* Product misuse
* Improper storage
* Improper sterilization
* Unauthorized modifications
* Off-label use
* Failure to follow instructions
* Failure to comply with recall notices
* Regulatory violations
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# 21. NO ADMISSION OF LIABILITY
Any investigation, communication, recall, replacement, refund, corrective action, or safety notice issued by the Company shall not constitute:
* Admission of fault
* Admission of negligence
* Admission of liability
* Admission of product defect
* Admission of legal responsibility
unless expressly stated in writing by an authorized representative of the Company.
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# 22. GOVERNING LAW
This Policy shall be governed by and construed in accordance with the laws of India.
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# 23. EXCLUSIVE JURISDICTION
All disputes arising from or relating to this Policy shall be subject exclusively to the competent courts located in New Delhi, India.
Users irrevocably submit to such jurisdiction.
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# 24. POLICY CHANGES
The Company reserves the right to modify, revise, replace, or update this Policy at any time without prior notice, unless otherwise required by applicable law.
Updated versions shall become effective upon publication on the Website.
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# 25. ACKNOWLEDGMENT
By purchasing, using, distributing, importing, exporting, recommending, or otherwise interacting with products sold through the Website, users acknowledge that:
* They have read this Product Recall & Adverse Event Reporting Policy.
* They understand this Policy.
* They agree to cooperate with safety investigations and recall activities.
* They agree to be legally bound by this Policy.
