BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTO SUTURE MULTIFIRE ENDO HERNIA 4.8MM DISPOSABLE LOADING U

    MDR report key: 140093 · Received December 22, 1997

    Report

    Report Number
    2647580-1997-01711
    Event Type
    Injury
    Date Received
    December 22, 1997
    Date of Event
    November 19, 1997
    Report Date
    November 25, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN INGUINAL HERNIA PROCEDURE. REPORTEDLY, THE STAPLES DID NOT FORM PROPERLY. THE SURGEON PERFORMED A RE-OPERATION ON NOVEMBER 25, 1997 TO CORRECT THE CONDITION. THE HOSP HAS REPORTED THE PT'S CONDITION IS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO SUTURE MULTIFIRE ENDO HERNIA 4.8MM DISPOSABLE LOADING U DISPOSABLE SURGICAL STAPLER GCJ UNITED STATES SURGICAL CORP. NA P7J234

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention