BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 3821837 · Received May 20, 2014

    Report

    Report Number
    2210968-2014-06401
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VETERINARIAN THAT AN ANIMAL UNDERWENT LIVER LOBECTOMY ON AN UNKNOWN DATE AND SUTURE WAS USED. FOUR DAYS FOLLOWING SURGERY, THE ANIMAL EXPERIENCED POST-OP SUTURE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299594 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK GJ5BQXN

    Patients

    Seq Age Sex Outcome Treatment
    1