BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPORT 20 IN X 16 IN 9153637574

    MDR report key: 4366496 · Received December 29, 2014

    Report

    Report Number
    1525712-2014-08230
    Event Type
    Malfunction
    Date Received
    December 29, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 20, 2014
    Manufacturer
    INVACARE REA AB
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    CLIENT HAS CALLED WHEELCHAIR SERVICES ((B)(4)) REPORTING A FAULT ON THE BACKREST BRACE. ONE OF THE TECHNICIANS HAS ATTENDED THE CALL AND FOUND OUT THAT THE RIGHT HAND PART OF THE BACK REST BRACE HAS DETACHED FROM THE RIGHT HAND BACK POST AS THE SCREW HOLDING IT IN PLACE HAS SNAPPED. THE AZALEA IS THE SAME /SIMILAR TO PRODUCTS WHICH ARE MANUFACTURED AND/OR MARKETED BY INVACARE IN THE U.S. THE ALLEGED INCIDENT OCCURED IN THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855376 TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL IOR INVACARE REA AB REA_AZALEA_STOCK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other