BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRSX5/WD66/ADULT/28FB/BH16/1255/U2222C/COM/U240 9153637780

    MDR report key: 4811613 · Received June 2, 2015

    Report

    Report Number
    9616091-2015-01382
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Report Date
    May 4, 2015
    Manufacturer
    INVAMEX
    Product Code
    IOR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    THE END USER STATES THE FRONT RIGGING IS STRIPPED. SHE STATES THE LEFT FRONT RIGGING WILL NOT LOCK INTO PLACE AND THE CALF-PAD IS BROKEN IN HALF. SHE STATES SHE HAS NO KNEE IN HER LEFT LEG AND NEEDS THE FRONT RIGGING FOR POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356350 TRSX5/WD66/ADULT/28FB/BH16/1255/U2222C/COM/U240 9153637780 WHEELCHAIR, MECHANICAL IOR INVAMEX TRSX56FB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other