BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2834901 · Received November 16, 2012

    Report

    Report Number
    2210968-2012-07262
    Event Type
    Injury
    Date Received
    November 16, 2012
    Report Date
    October 24, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-07963. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. WHEN REVIEWING THE REPORTED INFORMATION, IT WAS NOTED THAT THERE IS A DISCREPANCY BETWEEN THE MANUFACTURING DATE OF LOT NUMBER 3002695 AND THE PROCEDURE DATE. DUE TO LEGAL ACTIVITY IN THIS MATTER, AND BECAUSE ALL CONTACT MUST GO THROUGH LEGAL COUNSEL OR THEIR RESPECTIVE REPRESENTATIVES, (B)(4) CANNOT PERFORM A FOLLOW-UP TO THE CUSTOMER/PATIENT TO CLARIFY THESE DETAILS. THEREFORE, THE INFORMATION THAT WAS REPORTED WILL BE SUBMITTED IN THE MEDWATCH. IF ANY ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS FILE WILL BE UPDATED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH IMPLANTATION TO TREAT STRESS URINARY INCONTINENCE AND CYSTOCELE. DUE TO EROSION AND RECURRENT URGE INCONTINENCE THE PATIENT HAD MESH EXCISIONS ON (B)(6) 2010 AND ON (B)(6) 2011. POST IMPLANTATION THE PATIENT EXPERIENCED BLADDER, BACK, PELVIC AND VAGINAL PAIN, URGE INCONTINENCE, EROSION, DYSPAREUNIA, CHRONIC URINARY TRACT INFECTIONS, CONSTANT URINARY AND PELVIC PRESSURE, ANXIETY AND DEPRESSION. (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 USED. 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
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3002695

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention