BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHROMIC GUT SUTURE

    MDR report key: 149008 · Received February 12, 1998

    Report

    Report Number
    2648188-1998-00003
    Event Type
    Malfunction
    Date Received
    February 12, 1998
    Date of Event
    January 9, 1998
    Report Date
    January 13, 1998
    Manufacturer
    SHERWOOD DAVIS AND GECK
    Product Code
    GAL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE MFR COMPLAINT #MT1998-1-20-93, 94. SAMPLES WERE RETURNED AND EVALUATED. BRITTLENESS TESTING WAS PERFORMED AND THE NEEDLES DID NOT BREAK. STRENGTH TESTING WAS PERFORMED ON LOT 963253 AND FOUND TO BE WELL WITHIN SPECIFICATION. (THERE WERE INSUFFICIENT SAMPLES TO TEST LOT 953893.) REVIEW OF THE LOT HISTORY FOR EACH LOT WAS ACCEPTABLE. THE ACTUAL SAMPLE WAS NOT RETURNED. WITHOUT IT, CO IS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED BREAKAGE. CO'S TESTING INDICATED THE PRODUCT SHOULD HAVE PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS, AFTER SURGERON RETURNED 3-0 CHROMIC SUTURE, THE TIP OF THE NEEDLE WAS MISSING. THE NEEDLE HAD A FLATTENED APPEARANCE. REPORTEDLY, A SPECIMEN WAS SENT TO X-RAY, BUT THE NEEDLE WAS NOT FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHROMIC GUT SUTURE Implant SURGICAL SUTURE GAL SHERWOOD DAVIS AND GECK NA 963253,953593

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR