BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRSX5RC/WD66/28/R/AT903/U2222C/COM/U550 9153637779

    MDR report key: 4611393 · Received March 18, 2015

    Report

    Report Number
    9616091-2015-00713
    Event Type
    Malfunction
    Date Received
    March 18, 2015
    Report Date
    March 5, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Description of Event or Problem · 1

    THE TERRITORY BUSINESS MANAGER STATED THAT THE RIVET ON THE CROSS BRACE AT THE BASE OF THE FRAME WAS NEVER RIVETED; IT HAS CAUSED THE FRAME TO SHIMMY. THE TBM STATED IT COULD NOT BE REPAIRED IN THE FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184094 TRSX5RC/WD66/28/R/AT903/U2222C/COM/U550 9153637779 WHEELCHAIR, MECHANICAL IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other