BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETHILON NYLON SUTURE

    MDR report key: 5159981 · Received October 19, 2015

    Report

    Report Number
    2210968-2015-15339
    Event Type
    Malfunction
    Date Received
    October 19, 2015
    Date of Event
    September 23, 2015
    Report Date
    September 29, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A DISTRIBUTOR THAT ON (B)(6) 2015, IT WAS DISCOVERED THAT THE DEVICE HAD A MISPRINTED LABEL AND THE INFORMATION ON THE LABEL WAS INCORRECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690063 ETHILON NYLON SUTURE SUTURE, NONABSORBABLE, SYNTHETIC GAR ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1