BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DONJOY

    MDR report key: 434219 · Received December 18, 2002

    Report

    Report Number
    MW1027025
    Event Type
    Malfunction
    Date Received
    December 18, 2002
    Report Date
    December 11, 2002
    Manufacturer
    D.J. ORTHOPEDICS LLC
    Product Code
    IOY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    DONJOY ULTRA SLING II. CO STATES THAT RUBBER BALL PACKAGED WITH SLING CONTAINS NATURAL RUBBER. THERE IS NO LABELING ON PRODUCT LABEL THAT INDICATES THAT RUBBER CONTENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DONJOY ULTRA SLING II IOY D.J. ORTHOPEDICS LLC ULTRASLING II,BLK,S 112102

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other