BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSIMA PELVIC FLOOR REPAIR KIT

    MDR report key: 3103561 · Received May 9, 2013

    Report

    Report Number
    2210968-2013-05175
    Event Type
    Injury
    Date Received
    May 9, 2013
    Report Date
    April 18, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K063562
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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 TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-05169. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE, MENORRHAGIA, AND SYMPTOMATIC COMPARTMENT DEFECT AND MESH WAS IMPLANTED ALONG WITH THE CONCURRENT PROCEDURES OF HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED VAGINAL PAIN, MESH EXPOSURE, URINARY INCONTINENCE, ATROPHIC VAGINITIS, CONTINUED URINARY TRACT INFECTIONS, BLEEDING, PELVIC PAIN, VAGINAL PRESSURE AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON APPROXIMATELY (B)(6) 2013 DUE TO MESH EXPOSURE, VAGINAL PAIN AND WORSENING URINARY INCONTINENCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING EROSION, FORMATION OF SCAR TISSUE, ADDITIONAL SURGERIES AND NEUROLOGIC COMPROMISE TO HER STRUCTURES AND TISSUES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203096 PROSIMA PELVIC FLOOR REPAIR KIT MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3103158

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention