BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYPROPYLENE SUTURE

    MDR report key: 15227 · Received February 3, 1994

    Report

    Report Number
    2242353-1993-00001
    Event Type
    Injury
    Date Received
    February 3, 1994
    Date of Event
    December 30, 1993
    Report Date
    January 7, 1994
    Manufacturer
    LUKENS MEDICAL CORP.
    Product Code
    GAW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SEVEN DAYS POST-OP, SUTURE BROKE. PT RETURNED TO HOSPITAL DUE TO BLEEDING. PT WAS REOPENED AND ANASTOMOSIS REPAIRED. PT.'S CONDITION SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYPROPYLENE SUTURE SUTURE GAW LUKENS MEDICAL CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization| L| R