BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2934247 · Received January 30, 2013

    Report

    Report Number
    2210968-2013-00667
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    January 9, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MESH EXPOSURE. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED IN THIS FILE HAS BEEN DETERMINED TO BE A DUPLICATE OF THE EVENT REPORTED IN MW# 2210968-2013-00666. THEREFORE, THIS MEDWATCH 2210968-2013-00667 WILL BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED. DURING A FOLLOW-UP EXAM, THE PATIENT WAS FOUND TO HAVE A SMALL 1 CM MESH EROSION OF THE VAGINA. THE PATIENT WAS ADVISED TO USE A VAGIFEM PESSARY. THE PATIENT WAS SCHEDULED FOR SURGERY TO REPAIR THE EROSION AND FOR AN EXAMINATION UNDER ANAESTHESIA WITH POSSIBLE EXCISION OF EXPOSED MESH AND RECLOSURE OF THE VAGINAL WALL OVER THE EXPOSED MESH. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40386 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA DDB883

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention