Vigil
Device Complaint and MDR Clock
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Complaints
Report clocks
The file
Every complaint logged, every reportability decision written down, every MDR clock counted
Complaints
Who heard first and when, what happened, the harm, and the reportability decision with its reason.
Report clocks
30 calendar days, or 5 work days, from the day anyone at the company first heard.
The file
What is late, what is due, patterns by product, every decision - printable.
These Records
Where they are kept, and how to take them with you.
Complaints
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Log a complaint
first heard at the company on
Harm
the device malfunctioned
and could cause serious injury if it happened again
it needs remedial action (recall, correction) to prevent a substantial risk
FDA has asked for 5-day reports
Decision
not decided
reportable - file an MDR
not reportable
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Report clocks
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The file
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These Records
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