BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARB-EDGE, METZENBAUM SCISSORS, CURVED, 7"

    MDR report key: 2602373 · Received September 30, 2008

    Report

    Report Number
    2430952-2008-00028
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Report Date
    September 30, 2008
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR, (B)(4). CORRESPONDENCE SHOULD BE SENT TO: (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE BLADE BROKE MID-JAW AT THE HINGE WHILE IN A SURGICAL CASE. IT WAS BEING USED FOR A DISSECTION DURING A C-SECTION. ON (B)(6) 2008 THE INSTRUMENT WAS RECEIVED BUT THE SCREW WAS NOT INCLUDED. THE FACILITY WAS CONTACTED ON (B)(6) 2008 AND ASKED IF THE SCREW WAS RETRIEVED AND IF AN X-RAY WAS TAKEN. CURRENTLY PENDING A RESPONSE. REQUESTED ADD'L INFO FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARB-EDGE, METZENBAUM SCISSORS, CURVED, 7" NONE FWZ

    Patients

    Seq Age Sex Outcome Treatment
    1