BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMIC GUT 1 SUTURE

    MDR report key: 23976 · Received July 6, 1995

    Report

    Report Number
    23976
    Event Type
    Malfunction
    Date Received
    July 6, 1995
    Date of Event
    January 19, 1995
    Report Date
    January 24, 1995
    Manufacturer
    ETHICON AJ & J CO.
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN FOR TREATMENT OF UTERINE FIBROIDS. THE SURGEON WAS USING SUTURE TO REPAIR THE UTERUS WHEN THE NEEDLE BROKE FROM THE SUTURE. A PIECE WAS RETREIVED FROM THE SURGICAL FIELD AND THE BOX OF SUTURES WERE REMOVED FROM THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMIC GUT 1 SUTURE SUTURE GAL ETHICON AJ & J CO. 813/CT-1

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR