BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 3852999 · Received June 6, 2014

    Report

    Report Number
    2210968-2014-07204
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    December 13, 2013
    Report Date
    May 17, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 PATIENT UNDERWENT A MAMMOPLASTY ON (B)(6) 2013 AND SUTURE WAS USED. DURING THE PROCEDURE THE SUTURE BROKE. THE PROCEDURE WAS COMPLETED WITH A LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332945 ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UNK 457605

    Patients

    Seq Age Sex Outcome Treatment
    1