BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2770437 · Received October 3, 2012

    Report

    Report Number
    2210968-2012-05961
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 13, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    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. THIS IS ONE OF TWO MEDWATCHES SUBMITTED FOR THIS DEVICE. SEE ALSO MEDWATCH 2210968-2012-04927. THE SAME DEVICE IS REPRESENTED IN EACH MEDWATCH AS IT WAS INVOLVED IN TWO EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR AND POSTERIOR REPAIR PROCEDURE IN 2007 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED AN AREA OF MESH FOLDING WHICH CORRESPONDED WITH PAIN AND DISCOMFORT. THE FOLDED MESH WAS TREATED SURGICALLY AND THE PAIN RESOLVED AFTER THE RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention