BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREX2/WD66/ADULT/28/U550 9153637773

    MDR report key: 5074227 · Received September 14, 2015

    Report

    Report Number
    1525712-2015-04548
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Report Date
    August 18, 2015
    Manufacturer
    UNKNOWN
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    END USER STATED, THE HARDWARE FOR THE WHEELS WAS RUSTED, AND THE WHEEL LOCK TIPS WERE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604920 TREX2/WD66/ADULT/28/U550 9153637773 WHEELCHAIR, MECHANICAL IOR UNKNOWN TREX2

    Patients

    Seq Age Sex Outcome Treatment
    1 Other