BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER UNIVERSAL PERFORATED TRI-PANEL KNEE IMMOBILIZER

    MDR report key: 48362 · Received September 17, 1996

    Report

    Report Number
    1035617-1996-00007
    Event Type
    Malfunction
    Date Received
    September 17, 1996
    Date of Event
    May 6, 1996
    Report Date
    September 13, 1996
    Manufacturer
    ZIMMER PATIENT CARE DIVISION
    Product Code
    IQI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    APPROX 6-8 HRS AFTER IMMOBILIZER WAS APPLIED, PT ALLEGEDLY HAD THE EXTENSION AND ANKLE DORSIFLEXION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER UNIVERSAL PERFORATED TRI-PANEL KNEE IMMOBILIZER KNEE IMMOBILIZER IQI ZIMMER PATIENT CARE DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other