DAILY ACTIVITY ASSIST DEVICES 6497

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-07-30 for DAILY ACTIVITY ASSIST DEVICES 6497 manufactured by Unknown.

Event Text Entries

[20221703] Consumer called stating that the left side of the seat on her 6497 commode allegedly cracked from a bracket screw. The right side tubing that connects to the seat is allegedly cracking also. The consumer has been utilizing this commode since 2009. No injury alleged.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1531186-2012-00620
MDR Report Key2674360
Report Source*
Date Received2012-07-30
Date of Report2012-07-27
Date Facility Aware2012-07-02
Report Date2012-07-27
Date Reported to FDA2012-07-27
Date Added to Maude2012-11-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDAILY ACTIVITY ASSIST DEVICES
Generic Name890.5050
Product CodeINB
Date Received2012-07-30
Model Number6497
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerUNKNOWN
Manufacturer AddressOH US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-07-30

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