BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 3142261 · Received June 3, 2013

    Report

    Report Number
    2210968-2013-06369
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    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). 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 2210968-2013-06366. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO SYMPTOMATIC PELVIC RELAXATION. FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY & BOWEL PROBLEMS, RECURRENCE AND DYSPAREUNIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION, RIGHT LABIAL BIOPSY AND CYSTOSCOPY WITH BLADDER BIOPSY ON (B)(6) 2012 DUE TO PELVIC PAIN AND STRESS URINARY INCONTINENCE. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2013-06366. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT LAPAROSCOPIC ENTEROLYSIS AND CHOLECYSTECTOMY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION, LABIAL BIOPSY, CYSTO W/BLADDER BIOPSY ON (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT 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
    243097 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 3067816

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention