BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2902290 · Received January 8, 2013

    Report

    Report Number
    1525712-2013-00202
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Report Date
    January 8, 2013
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    MDR DECISION DATE: (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. PARTIAL SERIAL NUMBER WAS UNABLE TO BE VERIFIED. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    MDR DECISION DATE: (B)(6). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. PER DEALER, A BUNCH OF HAIR GOT TANGLED IN THE FORK AND STEM AREA DUE TO THE RESISTANCE CAUSED BY THIS, THE PATIENT LIFT WAS VERY HARD TO MANOEUVER. PER FOLLOW-UP CALL: (B)(6) 2013, THE INCIDENT WAS CLARIFIED THAT THIS INVOLVED A WHEELCHAIR ONLY HAIR GOT CAUGHT AND WHEELCHAIR IS DIFFICULT TO MANEUVER TO THE LEFT GOES TO RIGHT OK JUST LEFT. NO LIFT INVOLVED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9489 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other