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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LABORATORY DEVELOPED TEST
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LABORATORY DEVELOPED TEST Back to Search Results
Patient Problem Suicidal Ideation (4429)
Event Type  Death  
Event Description
The fda ignored a request for more information and my friend committed suicide.In vitro diagnostic devices ivd in vitro laboratory developed.Tracking proved false.D and l methamp.
 
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Brand Name
LABORATORY DEVELOPED TEST
Type of Device
LABORATORY DEVELOPED TEST
MDR Report Key18324362
MDR Text Key330481050
Report NumberMW5149210
Device Sequence Number1
Product Code OQS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 12/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/14/2023
Patient Sequence Number1
Patient Outcome(s) Death;
Patient SexFemale
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