BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 5542573 · Received April 1, 2016

    Report

    Report Number
    2210968-2016-07748
    Event Type
    Malfunction
    Date Received
    April 1, 2016
    Date of Event
    February 4, 2016
    Report Date
    March 14, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K964072
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Additional Manufacturer Narrative · 1

    CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THE FOIL PACKAGING AND DISPENSED SUTURES WERE VISUALLY INSPECTED AND NO DEVIATIONS WERE OBSERVED. THE SUTURES WERE FUNCTIONALLY TESTED AND RESULTS MET THE SPECIFIED QUALITY REQUIREMENTS. 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 THE PATIENT UNDERWENT A DENTAL SURGICAL PROCEDURE ON (B)(6) 2016 AND SUTURE WAS USED. THERE WAS NO REABSORPTION FROM (B)(6) 2016 AND THE THREAD HAS THE SAME ASPECT LIKE A THIRD DAY SUTURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198465 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK JH5BMDN

    Patients

    Seq Age Sex Outcome Treatment
    1