Just one note to add - I concur with everyone - if a complaint is related to an adverse event, it is beholden to file it within the statutory timelines. If further investigation reveals that the event was not device related or the device did not contribute, a supplemental can always be filed to that effect with rationale and conclusions. It will not remove the original filing, but it will complete the story.
My 2 cents worth.
Best!
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Manan Hathi RAC
Sr. Staff Regulatory Affairs Specialist
Stryker Communications
Flower Mound TX
United States
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Original Message:
Sent: 03-May-2017 19:26
From: Gaurang Bhavsar
Subject: Customer complaint
Agree with Elizabeth completely.
As it is serious adverse event occurred you have to file it with the latest information and your follow-up for additional information. complaint will remain open until you find out the root cause by investigation or audit. You may have to report additional information upon receipt in future.
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Gaurang Bhavsar
Edison NJ
United States
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Original Message:
Sent: 03-May-2017 12:19
From: Elizabeth Goldstein
Subject: Customer complaint
Hello,
If you become aware of a complaint related to a potential adverse event which meets reporting requirements, you need to report it, regardless of whether you have any information on the root cause, etc. Lack of detail does not exclude you from reporting requirements, however it is not uncommon not to receive requested followup information, so as long as you show due diligence, you shouldn't have an issue. Report the complaint and explain the follow-ups that you have made (e.g. the date(s), what was requested, etc.). Depending on the market, you may also need to file a follow-up report where you can reiterate follow-up attempts, provide any further information received, including the conclusion of any investigations (even if the conclusion is that the complaint can not be verified or the root cause cannot be determined due to lack of information or inability to retrieve the device for testing.
CFR - Code of Federal Regulations Title 21 (Part 803)
Hope this helps!
Liz
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Elizabeth Goldstein RAC
Regulatory Affairs Specialist
Medtronic Vascular
Santa Rosa CA
United States
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Original Message:
Sent: 02-May-2017 20:06
From: Anonymous Member
Subject: Customer complaint
This message was posted by a user wishing to remain anonymous
If there has been a complaint which is a potential adverse event , however there is lack of information after several follow-ups to establish whether it is device related , what should be the course of action , can the complaint remain open ? Can the event be reported without lack of evidence ? Or can we close the complaint documenting the communications ? IS there a guidance which mentions this scenario and the acceptable action from an audit point of view?
Thanks,