BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUIKART-SIMPSON

    MDR report key: 474596 · Received July 28, 2003

    Report

    Report Number
    MW1029117
    Event Type
    Injury
    Date Received
    July 28, 2003
    Date of Event
    June 26, 2000
    Report Date
    July 24, 2003
    Manufacturer
    ALLEGIANCE/V.MUELLER
    Product Code
    HCZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IN 2001, FACILITY RECEIVED A LETTER FROM ALLEGIANCE HEALTHCARE IN RESPONSE TO A REPORT OF BENDING FORCEPS BLADES. THE LETTER STATED THAT THE FAILURE WAS RELATED TO A METERIAL USED AT THE TIME OF FABRICATION. CONNUNICATION WITH ALLEGIANCE/V.MUELLER IN JUNE 2003, FOUND THAT LUIKART-SIMPSON FORCEPS MANUFACTURED PRIOR TO 1993 WITH LOT NUMBERS STARTING WITH THE LETTERS A THROUGH T, WERE MANUFACTURED WITH A SOFTER ALLOY THEN THE CURRENT DEVICES. THE SOFTER ALLOY ALLOWED THE FORCEPS TO BE BENT OUT OF SPECIFICATIONS. ALL LUIKART-SIMPSON OB FORCEPS MANUFACTURED PRIOR TO 1993 WERE REMOVED FROM THE FACILITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUIKART-SIMPSON OBSTETRICAL FORCEPS HCZ ALLEGIANCE/V.MUELLER * A THROUGH T

    Patients

    Seq Age Sex Outcome Treatment
    1 * Disability