BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED

    MDR report key: 3594710 · Received January 28, 2014

    Report

    Report Number
    2210968-2014-01088
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    December 30, 2013
    Report Date
    January 14, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION - REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR STRENGTH AND THEY MET REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, 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 A SPAY PROCEDURE AND SUTURE WAS USED. THE VET REPORTED THAT THE SUTURE BROKE 2- 3 DAYS POST OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62095 MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. DMM406

    Patients

    Seq Age Sex Outcome Treatment
    1