BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U.S.S.C. BIOSYN 0 60" VIOLET GS-24

    MDR report key: 285751 · Received July 12, 2000

    Report

    Report Number
    1219930-2000-00351
    Event Type
    Injury
    Date Received
    July 12, 2000
    Date of Event
    May 29, 2000
    Report Date
    June 15, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING A CESAREAN SECTION. REPORTEDLY, THE PT RETURNED TO THE HOSPITAL FOR A RE-OPERATION DUE TO EVISCERATION. THE HOSPITAL HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U.S.S.C. BIOSYN 0 60" VIOLET GS-24 MONOFILAMENT SYNTHETIC SUTURE GAN UNITED STATES SURGICAL CORP. NA A8M57

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention