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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREX; RAISED TOILET SEAT
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CAREX; RAISED TOILET SEAT Back to Search Results
Device Problem Unstable (1667)
Patient Problem Fall (1848)
Event Date 11/01/2018
Event Type  Injury  
Event Description
Consumer was injured when a carex raised toilet seat became unhinged.Further details regarding this event have not been provided.
 
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Brand Name
CAREX
Type of Device
RAISED TOILET SEAT
MDR Report Key8199908
MDR Text Key131514114
Report Number3012316249-2018-00065
Device Sequence Number1
Product Code ILS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/27/2018
Distributor Facility Aware Date12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age64 YR
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