BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPORT 20 IN X 16 IN 9153637574

    MDR report key: 4865292 · Received June 24, 2015

    Report

    Report Number
    9616091-2015-01620
    Event Type
    Malfunction
    Date Received
    June 24, 2015
    Report Date
    July 6, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT RETURNED AND EVALUATED. ITEM CONFIRMED TO HAVE A BROKE WELD AT THE RIGHT HAND GRIP. PRODUCT WAS NEW OUT OF THE BOX.

    Additional Manufacturer Narrative · 1

    FOLLOW UP TO BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS CHAIR ARRIVED DAMAGED. ONE OF THE PUSH CANES WAS BROKEN OFF AT THE WELD POINT. NO ADDITIONAL INFORMATION PROVIDED

    Description of Event or Problem · 1

    THIS CHAIR ARRIVED DAMAGED. ONE OF THE PUSH CANES WAS BROKEN OFF AT THE WELD POINT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409305 TRANSPORT 20 IN X 16 IN 9153637574 WHEELCHAIR, MECHANICAL IOR INVAMEX TRSX5RC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other