BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MECHANICAL (MANUAL) WHEELCHAIR

    MDR report key: 3130541 · Received May 24, 2013

    Report

    Report Number
    9616091-2013-00893
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COMPLAINT WAS NOT GIVEN TO REGULATORY AFFAIRS FOR PROCESSING UNTIL 05-23-2013.

    Description of Event or Problem · 1

    DEALER STATED THAT THE SEAT UPHOLSTERY ON A TREX28RF MANUAL WHEELCHAIR IS RIPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231399 MECHANICAL (MANUAL) WHEELCHAIR 890.3850 IOR INVAMEX TREX28RF

    Patients

    Seq Age Sex Outcome Treatment
    1 Other