BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS SUTURE

    MDR report key: 3922940 · Received July 9, 2014

    Report

    Report Number
    2210968-2014-08870
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 20, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VETERINARIAN THAT AN ANIMAL UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. PRIOR TO USE, THE NEEDLE DETACHED FROM THE SUTURE AS IT WAS PULLED FROM A NEWLY OPENED PACKAGE. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400336 MONOCRYL PLUS SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK GMM504

    Patients

    Seq Age Sex Outcome Treatment
    1