BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS SUTURE

    MDR report key: 3923303 · Received July 9, 2014

    Report

    Report Number
    2210968-2014-08875
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 19, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE NEEDLE WAS EXAMINED FOR ATTRIBUTE DEFECTS AND NO DEFECTS WERE OBSERVED. THE NEEDLE HAD A NORMAL SWAGED. ADDITIONALLY, THERE WERE NO MARKS ON THE NEEDLE BY USE OF THE NEEDLE HOLDER. THE END OF THE SUTURE WAS EXAMINED AND NO DEFECTS WERE FOUND. THE INSERTION END OF THE SUTURE WAS MEASURED AND THE SUTURE DID NOT HAVE SUFFICIENT INSERTION.

    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 AS THE VETERINARIAN WAS PULLING THE SUTURE FROM THE PACKET. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401174 MONOCRYL PLUS SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK GPZ507

    Patients

    Seq Age Sex Outcome Treatment
    1