DRIVE RTL12087

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-25 for DRIVE RTL12087 manufactured by Unknown.

MAUDE Entry Details

Report Number2438477-2019-00045
MDR Report Key8829133
Date Received2019-07-25
Date of Report2019-07-25
Date of Event2019-02-03
Date Facility Aware2019-02-26
Report Date2019-07-25
Date Reported to FDA2019-07-25
Date Added to Maude2019-07-25
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDRIVE
Generic NameTOILET SUPPORT
Product CodeILS
Date Received2019-07-25
Model NumberRTL12087
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Age1 YR
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-07-25

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