Hi. I was an FDA investigator (level II certified international medical device investigator) for over 21 years and now a contract international medical device consultant.
Complaints are tricky. You have 2 paths follow-
1. Is it a "FDA defined" complaint?
2. If so, is the complaint an "MDR: complaint?
i. If so, is it a 5 or 30 day MDR complaint?
What I mean is:
1. First, you have to determine whether the complaint is one that fits the FDA definition: any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution (taken from 21 CFR 820.3(b)).
2. If so, then follow 21 CFR 820.198. However, there are time constraints. Not only conducting the complaint investigation and corrective action in a timely fashion, but also determining whether the complaint is an MDR complaint. This type of complaint is a high risk complaint- basically one that involves a death, serious injury, or malfunction.
You either have 5, (10), or 30 calendar days to report the MDR to the FDA:
a. 10 days if you are a user facility.
b. 30 days if you are an importer or manufacturer. But there is a caveat
with the manufacturer. 5 or 30 days, depending upon the situation.
c. 5 days for a manufacturer if the MDR is one which is:
(i) A reportable event that requires remedial action to prevent an
unreasonable risk of substantial harm to the public health, or
(ii) A reportable event for which FDA made a written request.
From 21 CFR 803.3, an MDR reportable event means:
(1) An event that user facilities become aware of that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or
(2) An event that manufacturers or importers become aware of that reasonably suggests that one of their marketed devices:
(i) May have caused or contributed to a death or serious injury, or
(ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Note:
Serious injury means an injury or illness that:
(1) Is life-threatening,
(2) Results in permanent impairment of a body function or permanent damage to a body structure, or
(3) Necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Permanent means irreversible impairment or damage to a body structure or function, excluding trivial impairment or damage.
AND
Malfunction means the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed.