BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 3820290 · Received May 20, 2014

    Report

    Report Number
    2210968-2014-06348
    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

    CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 ANIMAL WAS SENT TO A DENTAL SPECIALIST ON (B)(6) 2014 FOR COMPLETION OF THE EXTRACTIONS. AT THAT TIME VETERINARY STAFF INDICATED THAT THE SUTURE WAS STARTING TO LOOSEN AND COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299500 VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK GCX332

    Patients

    Seq Age Sex Outcome Treatment
    1