BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 4132931 · Received October 1, 2014

    Report

    Report Number
    2210968-2014-14158
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 29, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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 BY A VETERINARIAN THAT AN ANIMAL UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. FOLLOWING THE PROCEDURE, THE ANIMAL EXPERIENCED POST-OPERATIVE SUTURE BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612823 VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK GL2635

    Patients

    Seq Age Sex Outcome Treatment
    1