BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGILENE, 7-0

    MDR report key: 18131 · Received December 1, 1994

    Report

    Report Number
    MW1004256
    Event Type
    Injury
    Date Received
    December 1, 1994
    Date of Event
    October 28, 1994
    Report Date
    November 22, 1994
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SUTURE BROKE AFTER FULL ANASTOMOSIS OF LIMA. REQUIRED RETURN TO PUMP FOR RE-SUTURING. NO ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGILENE, 7-0 SUTURE GAW DAVIS & GECK, INC. 3688-05

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention