BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE

    MDR report key: 1851259 · Received September 23, 2010

    Report

    Report Number
    2210968-2010-01178
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    April 11, 2010
    Report Date
    August 24, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ONE REPRESENTATIVE SAMPLE WAS RETURNED FOR EVALUATION. IT WAS VISUALLY AND FUNCTIONALLY EXAMINED FOR KNOT TENSILE STRENGTH AND IT MET THE REQUIREMENTS. CONCLUSIONS: THE DEVICE WAS RECEIVED IN A CONDITION THAT MEETS SPECIFICATION. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED FOR THE SAME PATIENT. SEE ALSO MEDWATCH 2210968-2010-01177, 2210968-2010-01179 AND 2210968-2010-01180.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTEBRACHIUM PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED TO SEW "REAL LEATHER" DISCONTINUOUSLY. TWO DAYS AFTER THE PROCEDURE, THE SURGEON FOUND THE SUTURE WAS BROKEN. NOW THE PATIENT'S WOUND HAS HEALED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA BM2257

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR