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Reporting of AE to FDA
We currently have a question we are unable to find an answer to. Scenario: A box contains 200 individually wrapped products. Each individually wrapped product seems to have a loose fray that is visible to the customer. Event = "Loose fray on Product A package." One Event, One product, 200 qty. Our question is as follows: Do we report 200 individual reports, or do we report 1 report specifying that 200 products were associated with the event?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Expert
Verlene Law
Feb 04, 2019
MDR 3500 doesn't contain a qty field.
Answer:
You should submit one report of this product if the all the 200 individually wrapped product belongs to a single lot . You should also refer to your local regulatory guideline for clarification.
For more information, please refer to :
How to comply with ISO 13485:2016 requirements for handling complaints
https://advisera.com/13485academy/blog/2017/03/21/how-to-comply-with-iso-134852016-requirements-for-handling-complaints/
Answer:
You should submit one report of this product if the all the 200 individually wrapped product belongs to a single lot . You should also refer to your local regulatory guideline for clarification.
For more information, please refer to :
How to comply with ISO 13485:2016 requirements for handling complaints
https://advisera.com/13485academy/blog/2017/03/21/how-to-comply-with-iso-134852016-requirements-for-handling-complaints/
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Feb 04, 2019
Feb 04, 2019
Feb 04, 2019