BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USSC SURGIPRO

    MDR report key: 79392 · Received March 25, 1997

    Report

    Report Number
    2647580-1997-00279
    Event Type
    Malfunction
    Date Received
    March 25, 1997
    Date of Event
    February 27, 1997
    Report Date
    February 27, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A MICRO VALVE REDUCTION PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER SUTURE. THE HOSPITAL REPORTED THAT NO PT INJURY HAD OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USSC SURGIPRO Implant POLYPROPYLENE SUTURE GAW UNITED STATES SURGICAL CORP. NA T6M89KW

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR