BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN

    MDR report key: 489710 · Received October 2, 2003

    Report

    Report Number
    MW1029725
    Event Type
    Malfunction
    Date Received
    October 2, 2003
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GAJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    END OF STRIPPER CAME OFF AND REMAINED IN THE LEG. DR. WAS ABLE TO RETRIEVE THE REMAINDER.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 1/14/04: MFR EXAMINED THE DEVICE TO THE EXTENT POSSIBLE FOR CONFORMANCE TO SPECIFICATIONS. MFR FOUND THE COMPONENTS OF THE DEVICE TO MEET SPECIFICATIONS. MFR ALSO REVIEWED THE LOT HISTORY RECORDS AND FOUND NO PROBLEMS IN THIS DOCUMENTATION. ALL UNITS IN THE BATCH THAT WERE RELEASED HAD MET A 50-POUND TENSILE PROOF-LOAD PRIOR TO ACCEPTANCE. MFR PULL TESTED OTHER UNITS FROM THIS LOT THAT HAD BEEN RETURNED TO CO FROM THE REPORTER OF THIS EVENT. ALL UNITS TESTED READILY EXCEEDED THE 50-POUND REQUIREMENT. MFR HAS CONCLUDED THAT FORCES WERE USED DURING CLINICAL USE THAT FAR EXCEEDED ANTICIPATED, NORMAL USE CONDITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN VEIN STRIPPER GAJ CODMAN & SHURTLEFF, INC. * FV496

    Patients

    Seq Age Sex Outcome Treatment
    1 *