BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 4130068 · Received September 30, 2014

    Report

    Report Number
    2210968-2014-14099
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THAT A CAT UNDERWENT AN OVARIOHYSTERECTOMY PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. THIS CAT CHEWED OUT ITS SKIN SUTURES THE NIGHT AFTER THE PROCEDURE. THE INTERNAL SUTURE WAS THOUGHT TO BE INTACT AT THAT TIME. THE FOLLOWING DAY IT WAS NOTED THAT THE SUTURE EITHER BROKE OR THE KNOT UNTIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608096 VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK HA2350

    Patients

    Seq Age Sex Outcome Treatment
    1