BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRACER SX5 RECLINER WHEELCHAIR

    MDR report key: 9316624 · Received November 13, 2019

    Report

    Report Number
    9616091-2019-00027
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    October 9, 2019
    Report Date
    November 11, 2019
    Manufacturer
    INVAMEX MANUFACTURING
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CALLER RELATED THAT THE REAR WHEELS ON THE CHAIR HAVE BIG CHUNKS OF RUBBER MISSING FROM THEM, THE WHEEL LOCKS GET CAUGHT WHERE THE PIECES ARE MISSING ON THE WHEELS AND THE CHAIR SLIPS. THE USER MANUAL PART # 1110550 PAGE 29 STATES: INSPECT/ADJUST WEEKLY ENSURE THAT THE WHEEL LOCKS PREVENT THE WHEELCHAIR FROM MOVING WHEN ENGAGED. INSPECT TIRES FOR FLAT SPOTS AND WEAR. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT WAS TRYING TO SELF-TRANSFER FROM HER BED TO THE WHEELCHAIR AND DID NOT HAVE THE BREAKS LOCKED PROPERLY. THE WHEELCHAIR MOVED DURING THE TRANSFER AND THE PATIENT FELL TO THE FLOOR FRACTURING HER FEMUR, REQUIRING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109505 TRACER SX5 RECLINER WHEELCHAIR WHEELCHAIR, MECHANICAL IOR INVAMEX MANUFACTURING NA:TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O