BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYO/WIRE II

    MDR report key: 2943769 · Received January 28, 2013

    Report

    Report Number
    2943769
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ALTO DEVELOPMENT CORP, DBA A&E MEDICAL
    Product Code
    GAO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    STAFF IN CARDIAC SURGERY HAVE HAD DIFFICULTIES WITH OPENING THE STERILE PACKAGE OF STAINLESS STEEL WIRES. NURSE ATTEMPTED BOTH ENDS AND WHITE PLASTIC WOULD RIP AND NOT ALLOW PACKAGE TO BE OPENED IN A STERILE FASHION. THREE SEPARATE PACKAGES WERE ATTEMPTED WITHOUT SUCCESS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?OPENING STERILE PRODUCT FOR OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38313 MYO/WIRE II STERNOTOMY SUTURE GAO ALTO DEVELOPMENT CORP, DBA A&E MEDICAL 045-032 0455S

    Patients

    Seq Age Sex Outcome Treatment
    1 *