BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 2991324 · Received March 6, 2013

    Report

    Report Number
    2210968-2013-02135
    Event Type
    Injury
    Date Received
    March 6, 2013
    Report Date
    February 18, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED DUE TO PELVIC ORGAN PROLAPSE. THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, FISTULAE, RECURRENCE, BLEEDING, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. ON (B)(6) 2012, THE PATIENT UNDERWENT COLOPLAST RESTORELLE IMPLANT DUE TO PELVIC ORGAN PROLAPSE. THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO MESH EROSION. THE PATIENT UNDERWENT SUBCUTANEOUS ANAL FISTULECTOMY ON (B)(6) 2012 FOR ANAL FISTULA. THE PATIENT UNDERWENT MESH REMOVAL FROM POSTERIOR VAGINAL MUCOSA TWICE ON (B)(6) 2012 AND VAGINAL MESH REMOVAL ON (B)(6) 2013 FOR MESH EROSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2011 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
    95313 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA CJB052

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention