BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 3820282 · Received May 20, 2014

    Report

    Report Number
    2210968-2014-06347
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Report Date
    April 29, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. 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 ROUTINE DENTAL EXTRACTION ON (B)(6) 2014 AND SUTURE WAS USED. THE SITE WAS RECHECKED ONE WEEK LATER AND THE SUTURE KNOTS WERE UNTYING POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299801 VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. GCX332

    Patients

    Seq Age Sex Outcome Treatment
    1