BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3250423 · Received July 26, 2013

    Report

    Report Number
    2210968-2013-14745
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    July 1, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED DUE TO SUI. THE PATIENT EXPERIENCED INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXPLANT ON (B)(6) 2008 DUE TO EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE CONCURRENTLY WITH CYSTOCELE REPAIR AND RECTOCELE REPAIR WITH MESH.

    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.

    Additional Manufacturer Narrative · 1

    IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS ALSO REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF INTERNAL TISSUES, AND HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349649 GYNECARE GYNEMESH* PS MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC. UNK UDP527

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention