BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS CLAMP

    MDR report key: 490818 · Received October 16, 2003

    Report

    Report Number
    1035617-2003-00004
    Event Type
    Malfunction
    Date Received
    October 16, 2003
    Date of Event
    September 2, 2003
    Report Date
    September 19, 2003
    Manufacturer
    ZIMMER ORTHOP SURGICAL PRODUCTS
    Product Code
    ILZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POST-OP PATIENT IN NEW HILLROM TOTAL CARE BED WITH NEW 4 POSTER OVERHEAD FRAME (ZIMMER) - USED THE OVERHEAD TRAPEZE TO PULL THEMSELVES UP IN BED AND THE CROSS CLAMP ALLEGEDLY BROKE IN HALF, CAUSING THE TRAPEZE TO FALL ONTO PATIENT RESULTING IN A LACERATION ON APPARATUS HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSS CLAMP TRACTION ACCESSORIES ILZ ZIMMER ORTHOP SURGICAL PRODUCTS * NI

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other