BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH

    MDR report key: 4240772 · Received November 10, 2014

    Report

    Report Number
    2210968-2014-15522
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    May 5, 2014
    Report Date
    October 21, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF MAUDE EVENT REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR REPAIR PROCEDURE IN 2004 AND MESH WAS IMPLANTED. THE PATIENT EXPERIENCED VAGINAL BLEEDING, DYSPAREUNIA, VAGINA PAIN, AND BLADDER PAIN. MESH EROSION WAS NOTED AND THE PATIENT DESIRED SURGICAL REMOVAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723886 GYNECARE GYNEMESH MESH, SURGICAL, POLYMERIC OTO ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention