BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USSC SURGIPRO 1

    MDR report key: 73168 · Received February 25, 1997

    Report

    Report Number
    1219161-1997-00191
    Event Type
    Malfunction
    Date Received
    February 25, 1997
    Date of Event
    January 16, 1997
    Report Date
    January 27, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE DEVICE WAS USED FOR ABDOMINAL CLOSURE. THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE HOSP REPORTED THAT NO PT INJURY HAD OCCURRED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN