BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    USSC SURGIPRO 3/0

    MDR report key: 73455 · Received February 28, 1997

    Report

    Report Number
    1219161-1997-00211
    Event Type
    Malfunction
    Date Received
    February 28, 1997
    Date of Event
    February 12, 1997
    Report Date
    February 20, 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 AN UNSPECIFIED PROCEDURE, THE SUTURE BROKE. THE SURGEON APPLIED ANOTHER DEVICE. THE HOSP HAS REPORTED THAT NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 USSC SURGIPRO 3/0 Implant POLYPROPYLENE SUTURE GAW UNITED STATES SURGICAL CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN