BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXON II

    MDR report key: 87949 · Received May 1, 1997

    Report

    Report Number
    9681850-1997-00007
    Event Type
    Malfunction
    Date Received
    May 1, 1997
    Report Date
    April 1, 1997
    Manufacturer
    DAVIS & GECK, INC.
    Product Code
    GAN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIRTY-THREE SAMPLES WERE RETURNED FOR EVALUATION. RETURNED SAMPLES WERE EXAMINED AND EVALUATED BY TINIUS OLSEN TESTING. ALL SAMPLES MET THE SUPPLIERS SPECIFICATIONS. A SEARCH OF THE LOT HISTORY WAS UNREMARKABLE WITH REGARD TO THE COMPLAINT. TWO DIFFERENT NEEDLE LOTS WERE ISSUED DURING THE PRODUCTION OF THIS LOT. HOWEVER, BOTH NEEDLE LOTS MET ALL RELEASE CRITERIA. A SEARCH OF CO'S RECORDS FINDS NO OTHER REPORTS AGAINST THIS LOT. CO BELIEVES THIS PRODUCT SHOULD HAVE PERFORMED SATISFACTORILY, UNDER NORMAL CONDITIONS OF USE.

    Description of Event or Problem · 1

    CUSTOMER REPORTS, PINPOINTS ARE BREAKING OFF VERY SHORT IN A FACE/NOSE PLASTIC SURGERY PROCEDURE. THERE WAS A FIVE MINUTE DELAY DURING THE OPERATION. THE NEEDLE FRAGMENT WAS RETRIEVED WITHOUT X-RAY INVOLVEMENT. THERE WAS NO INJURY INVOLVED DURING THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXON II Implant SURGICAL SUTURE GAN DAVIS & GECK, INC. NA 447452

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN