BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE GYNEMESH* PS

    MDR report key: 3021515 · Received March 26, 2013

    Report

    Report Number
    2210968-2013-02983
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    February 25, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - UNDEFINED URINARY/BOWEL PROBLEMS; DYSPAREUNIA. 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. THIS IS ONE OF THREE MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-01142 AND MEDWATCH 2210968-2013-02984. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT A RECURRENT THIRD DEGREE RECTOCELE, SECOND DEGREE VAGINAL WALL PROLAPSE, SECOND DEGREE CYSTOCELE AND STRESS URINARY INCONTINENCE ON (B)(6) 2009, IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ABDOMINAL SACROCOLPOPEXY WITH MESH, MOSKOWITZ CULDOPLASTY, TENSION FREE VAGINAL TAPE SLING, CYSTOSCOPY AND PERINEOPLASTY. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL AND CYSTOTOMY ON (B)(6) 2007 FOR MESH EROSION.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO TREAT VAGINAL VAULT PROLAPSE, STRESS URINARY INCONTINENCE AND BLADDER EROSION ON (B)(6) 2009 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION, THE PATIENT EXPERIENCED PAIN, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, FISTULAE AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124693 GYNECARE GYNEMESH* PS MESH, SURGICAL, POLYMERIC OTO ETHICON, INC. NA AEE127

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention