BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403

    MDR report key: 4945167 · Received July 28, 2015

    Report

    Report Number
    9616091-2015-01913
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Report Date
    July 1, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGED THE CANES FOR THE CHAIR HAVE BROKEN AT THE WELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491966 TRSX5/WD08/AD/28/34P/U240/1255/U2222/AHDRM/9691B/GVT93HC/G1360/BH16 9153649403 WHEELCHAIR, MECHANICAL IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other