BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS SUTURE

    MDR report key: 3890156 · Received June 24, 2014

    Report

    Report Number
    2210968-2014-08073
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. MICROSCOPIC EVALUATION FOUND THE NEEDLE EXHIBITED AMOUNTS OF INTERGRANULAR AND POSSIBLY SOME TRANSGRANULAR FAILURE.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFORMATION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON 6/3/2014 DURING A VETERINARY PROCEDURE THE NEEDLE PULLED OFF THE SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368159 MONOCRYL PLUS SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK GLK604

    Patients

    Seq Age Sex Outcome Treatment
    1