BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRSX5/WD06/ADULT/28FB/BH16/1228/U2222C//U240 9153653560

    MDR report key: 5027280 · Received August 25, 2015

    Report

    Report Number
    9616091-2015-02144
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Report Date
    July 31, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOR THE PATIENT, A SUPPLEMENTAL RECORD WILL BE FILED.

    Description of Event or Problem · 1

    THE DEALER STATED THE FRAME IS BENT OUT OF THE BOX. WHERE THE SEAT ATTACHES TO THE FRAME. PER THE RETURNS EXPANDED EVALUATION REPORT FORM, BOTH SEAT RAILS WERE BENT INWARDS AND DID NOT SETTLE INTO THE H-BLOCKS. THE COMPLAINT IS CONFIRMED FOR THE BENT FRAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560187 TRSX5/WD06/ADULT/28FB/BH16/1228/U2222C//U240 9153653560 WHEELCHAIR, MECHANICAL IOR INVAMEX TRSX50FBP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other