BEUDAMED
    FDA Adverse Event Other Summary report: N

    WHEELCHAIR, BARIATRIC, 28", REM

    MDR report key: 1008019 · Received March 4, 2008

    Report

    Report Number
    1417592-2008-00005
    Event Type
    Other
    Date Received
    March 4, 2008
    Report Date
    March 3, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT INVOLVED A FEMALE PT WHO WENT TO SIT DOWN ON THE WHEEL CHAIR. APPARENTLY, IT WAS NOT OPEN ALL THE WAY. SHE PLACED HER HAND AROUND THE SEAT FRAME AND SAT DOWN. WHEN IT FULLY OPENED, HER FINGER WAS CAUGHT AND SHE SUFFERED A LACERATION. THE LACERATION REQUIRED SUTURES. NO COMPLICATIONS AFTER THE LACERATION REPAIR WERE REPORTED. THE SAMPLE WAS EVALUATED. WARNING STICKERS ARE FOUND ON EITHER SIDE OF THE SEAT FRAME CAUTIONING THE END USER NOT TO PLACE FINGERS AROUND THE SEAT TUBES. THE OWNER'S MANUAL ALSO STATES FINGERS SHOULD BE KEPT WAY FROM PINCH POINTS UNDER THE SEAT TUBES WHILE OPENING THE CHAIR.

    Description of Event or Problem · 1

    A PT SAT DOWN ON THE WHEELCHAIR WHICH WAS NOT FULLY OPEN. SHE PLACED HER HAND AROUND THE SEAT FRAME, AND WHEN IT COMPLETELY OPENED, HER FINGER WAS CAUGHT. SHE SUFFERED A LACERATION WHICH REQUIRED SUTURES TO REPAIR IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEELCHAIR, BARIATRIC, 28", REM WHEELCHAIR IOR MEDLINE INDUSTRIES, INC. MDS809850 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention