BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH

    MDR report key: 3162853 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10122
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED, CONCURRENTLY WITH A RECTOCELE REPAIR, AND PERINEOPLASTY. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009 DUE TO EROSION AND VAGINAL FOREIGN BODY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262955 GYNECARE GYNEMESH MESH, SURGICAL, POLYMERIC OTO ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention