BEUDAMED
    FDA Adverse Event Injury Summary report: N

    U.S.S.C. BIOSYN 2/0 U/D GU-45

    MDR report key: 279946 · Received May 25, 2000

    Report

    Report Number
    1219930-2000-00252
    Event Type
    Injury
    Date Received
    May 25, 2000
    Report Date
    April 28, 2000
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SUTURE WAS USED DURING A PROSTECTOMY. REPORTEDLY, THE PT HAD AN ALLERGIC REACTION TO THE SUTURE. THE SURGEON PERFORMED A RE-OPERATION TO CORRECT THE CONDITION. 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 2/0 U/D GU-45 MONOFILAMENT SYNTHETIC SUTURE GAN UNITED STATES SURGICAL CORP. NA A9J264

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention