BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2760523 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05643
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 7, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. (B)(4). 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 2210968-2012-05646 AND 2210968-2012-05642 . THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH HYSTERECTOMY AND RECTAL PERINEAL REVISION; DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INFLAMED CHRONIC PAINFUL AREAS, DYSPAREUNIA, BAND TOO TIGHT, VAGINAL PAIN, VAGINAL BLEEDING, URINARY PROBLEMS, INCONTINENCE, ABDOMINAL PELVIC PAIN, VOIDING ISSUES - BLADDER CONTROL, PAIN. IT WAS REPORTED THE PATIENT WAS TREATED FOR PROLAPSE ON (B)(6) 2007 AND REVISION OF MESH ON (B)(6) 2007. IT WAS REPORTED THE PATIENT EXPERIENCED VAGINAL MESH EROSION AND HAD THE MESH REVISION ON (B)(6) 2007. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF VAGINAL MESH EROSION ON (B)(6) 2013. (B)(4) ¿ URINARY PROBLEMS ; DYSURIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND (B)(6) 2007 AND MESH WAS USED. IT WAS NOT STATED WHICH PRODUCT WAS IMPLANTED DURING WHICH SURGERY. 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
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3028596

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention