BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USSC SURGIPRO 5/0

    MDR report key: 126726 · Received October 14, 1997

    Report

    Report Number
    1219930-1997-02228
    Event Type
    Malfunction
    Date Received
    October 14, 1997
    Report Date
    September 15, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    12/03/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A VARICOSE VEIN PROCEDURE. REPORTEDLY, THE SUTURE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USSC SURGIPRO 5/0 Implant POLYPROPYLENE SUTURE GAW UNITED STATES SURGICAL CORP. NA A5L164WU

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN