BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N/A

    MDR report key: 5911678 · Received August 29, 2016

    Report

    Report Number
    3005182235-2016-00025
    Event Type
    Injury
    Date Received
    August 29, 2016
    Date of Event
    August 7, 2016
    Report Date
    October 10, 2016
    Manufacturer
    N/A
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER/END-USER REPORTED THAT THE WHEELCHAIR'S FRAME CRACKED WHILE HE WAS DRIVING IT AROUND HIS MOTHER'S POOL. THE FRAME CRACKED WHERE THE WHEELS GO INTO IT. THE END-USER HAD TO GO TO THE HOSPITAL, AND RECEIVED 12 STITCHES FROM FALLING FORWARD. THE END-USER IS ON DISABILITY.

    Description of Event or Problem · 1

    DEVICE WAS RETURNED TO COMPASS HEALTH BRANDS, AND EVALUATED ON 9/16/2016. UPON INSPECTION, THE UNIT WAS FOUND TO BE USED WITH HEAVY WEAR, AND A LOT OF RUST. THE CUSTOMER STATED THAT THE FRAME CRACKED WHERE THE WHEELS GO INTO THE FRAME. THE CUSTOMER IS CORRECT, THE FRAME JUST ABOVE THE WELD WHERE THE CASTER WHEEL CYLINDER SLIDES INTO HAS CRACKED. THE LEFT SIDE WHEEL HAS COMPLETELY DETACHED FROM THE WHEELCHAIR DUE TO THE CRACKED/BROKEN FRAME. THE RIDE SIDE IS CRACKED IN THE SAME SPOT, BUT THE CASTER WHEEL IS STILL ATTACHED. BOTH ARMREST CUSHIONS ARE RIPPED, AND THE FOAM IS EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562436 N/A N/A IOR N/A N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R