BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 2872934 · Received December 13, 2012

    Report

    Report Number
    9616091-2012-00638
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    December 13, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. THE REPAIR TECHNICIAN STATES THAT THE ARM BROKE AT THE POINT WHERE IT CONNECTS TO THE CHAIR ON THE RIGHT SIDE. HE ALSO ALLEGES THAT THE ARM IS CRACKED. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX 9XDT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other