BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGILENE 6-0

    MDR report key: 18130 · Received December 1, 1994

    Report

    Report Number
    MW1004255
    Event Type
    Injury
    Date Received
    December 1, 1994
    Date of Event
    October 20, 1994
    Report Date
    November 22, 1994
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    GAW
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    SUTURE FAILED FOLLOWING PT CAROTID ENDARTERECTOMY REQUIRING ADDITIONAL SURGERY TO REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGILENE 6-0 Implant SUTURE GAW DAVIS & GECK, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention