BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS ANTIBACTERIAL SUTURES

    MDR report key: 2933389 · Received January 29, 2013

    Report

    Report Number
    2210968-2013-00626
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    December 31, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED AS THREE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCHES 2210968-2013-00624 AND 2210968-2013-00625. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. WHILE MAKING THE KNOT, THE SUTURE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39467 MONOCRYL PLUS ANTIBACTERIAL SUTURES SUTURE, ABSORBABLE GAN ETHICON, INC. NA EBZ763

    Patients

    Seq Age Sex Outcome Treatment
    1