BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGILENE SUTURE

    MDR report key: 78103 · Received March 21, 1997

    Report

    Report Number
    2648188-1997-00008
    Event Type
    Malfunction
    Date Received
    March 21, 1997
    Report Date
    February 20, 1997
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    GAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REP REPORTS, NEEDLE FELL OFF OF SUTURE DURING AN EVALUATION CASE, CREATING A 10-15 MINUTE LOST NEEDLE SEARCH. THE REP REPORTS AT NO TIME WAS ANY PRESSURE EXERTED ON THE NEEDLE. IT WAS ONLY ON LOOSE END, WHILE THE OTHER END WAS BEING USED TO SUTURE AND TIE, ETC. THE NEEDLE WAS FOUND IN A FOLD OF THE SURGICAL DRAPE, NEXT TO A CLAMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGILENE SUTURE Implant SURGICAL SUTURE GAW SHERWOOD DAVIS AND GECK N/A 948255

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN