BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHEELCHAIR, BARIATRIC, 28", REM D

    MDR report key: 868103 · Received June 19, 2007

    Report

    Report Number
    1417592-2007-00031
    Event Type
    Other
    Date Received
    June 19, 2007
    Report Date
    June 14, 2007
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IOR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE WHEELCHAIRS DETERMINED THAT THE UPHOLSTERY ON THE BACK OF THE CHAIR WAS TOO TIGHT. THAT, IN CONJUNCTION WITH STAFF MEMBERS PLACING THEIR FINGERS IN A VULNERABLE POSITION WHEN OPENING THE CHAIR, RESULTED IN THE FINGERS GETTING PINCHED. THE OWNER'S MANUAL STATES THAT FINGERS SHOULD BE KEPT AWAY FROM PINCH POINTS UNDER SEAT TUBE WHEN OPENING CHAIR. THERE ARE ALSO STICKERS ON THE WHEELCHAIRS TO VISUALLY ALERT THE END USER. AS A CORRECTIVE ACTION RELATED TO THE FABRIC, THE WIDTH OF THE MATERIAL ON THE BACK OF THE CHAIR HAS BEEN INCREASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE WHEELCHAIRS ARE OPENING TOO QUICKLY AND THE FACILITY'S STAFF ARE GETTING THEIR FINGERS PINCHED. THE NUMBER AND EXTENT OF ANY INJURIES IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR, BARIATRIC, 28", REM D NONE IOR MEDLINE INDUSTRIES, INC. MDS809850 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other