BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL PLUS SUTURE

    MDR report key: 4093728 · Received September 16, 2014

    Report

    Report Number
    2210968-2014-12935
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    July 31, 2014
    Report Date
    August 26, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K050845
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CAT UNDERWENT AN OVARIOHYSTERECTOMY ON (B)(6) 2014 AND SUTURE WAS USED. ON (B)(6) 2014, IT WAS NOTED THAT THE SUTURE WAS IN PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573049 MONOCRYL PLUS SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK GKK902

    Patients

    Seq Age Sex Outcome Treatment
    1