BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U.S.S.C. SURGIPRO

    MDR report key: 130329 · Received October 31, 1997

    Report

    Report Number
    1219161-1997-01568
    Event Type
    Malfunction
    Date Received
    October 31, 1997
    Report Date
    October 2, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    11/13/1997-SUPPLEMENT #1 SENT TO FDA.

    Description of Event or Problem · 1

    THE PRODUCT WAS USED DURING AN UNSPECIFIED PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE HOSP HAS REPORTED NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN