BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PAVILIK HARNESS

    MDR report key: 381121 · Received March 6, 2002

    Report

    Report Number
    1035617-2002-00002
    Event Type
    Malfunction
    Date Received
    March 6, 2002
    Report Date
    March 4, 2002
    Manufacturer
    ZIMMER ORTHO SURGICAL PRODUCTS
    Product Code
    IOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE HARNESS WAS FITTED TO AN INFANT, THE CHILD SEEMED TO BE IN SOME DISCOMFORT AND WOULD NOT STOP CRYING. ON EXAMINATION OF THE HARNESS THE POINT OF AN INDUSTRIAL SEWING NEEDLES WAS ALLEGEDLY DISCOVERED EMBEDDED IN THE LINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PAVILIK HARNESS HIP ABDUCTION SPLINT IOZ ZIMMER ORTHO SURGICAL PRODUCTS * 60110011

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Required Intervention