BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U.S.S.C. POLYSORB 2/0

    MDR report key: 121708 · Received September 18, 1997

    Report

    Report Number
    1219930-1997-02062
    Event Type
    Malfunction
    Date Received
    September 18, 1997
    Report Date
    August 21, 1997
    Manufacturer
    UNITED STATES SURGICAL CORP.
    Product Code
    GAM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    12/03/1997-SUPPLEMENTAL REPORT #1 SUBMITTED TO FDA.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN APPENDIX PROCEDURE. REPORTEDLY, THE SUTURE BROKE. THE HOSP HAS REPORTED NO PT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U.S.S.C. POLYSORB 2/0 Implant SYNTHETIC ABSORBABLE SUTURE GAM UNITED STATES SURGICAL CORP. NA A5J647HKU

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN