BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 6262376 · Received January 18, 2017

    Report

    Report Number
    2210968-2017-30287
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Date of Event
    October 25, 2016
    Report Date
    December 19, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. ACCORDING THE SAMPLE CONDITION, NO DEFECTS OR SUTURE BREAKAGE WAS OBSERVED ON THE SAMPLE AND THE REPRESENTATIVE SAMPLE MET THE REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DOG UNDERWENT AN FHO SURGERY ON (B)(6) 2016 AND SUTURE WAS USED. POST-OPERATIVELY, THE SURGEON VISUALIZED THE PREVIOUSLY PLACED SUTURE MATERIAL HAD BROKEN UP INTO SMALL PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45570 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK KB6906

    Patients

    Seq Age Sex Outcome Treatment
    1