BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USSC SURGIPRO 1

    MDR report key: 71608 · Received February 21, 1997

    Report

    Report Number
    1219930-1997-00413
    Event Type
    Malfunction
    Date Received
    February 21, 1997
    Date of Event
    January 23, 1997
    Report Date
    January 23, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A BOWEL RESECTION PROCEDURE, THE SUTURE BROKE. THE SURGEON COMPLETED THE SURGERY WITHOUT PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USSC SURGIPRO 1 Implant POLYPROPYLENE SUTURE GAW UNITED STATES SURGICAL CORP. NA A6K972HK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN