BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2851115 · Received November 29, 2012

    Report

    Report Number
    2210968-2012-07613
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 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
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT RECURRENT URINARY INCONTINENCE, VAGINAL MESH EXPOSURE/EXTRUSION AND A RECURRENT VAGINAL PROLAPSE ON (B)(6) 2010 AND MESH WAS USED. DURING MESH IMPLANTATION ON 07/23/2010 THE PATIENT EXPERIENCED THE COMPLICATION OF A BLADDER PERFORATION. THE PATIENT EXPERIENCED PAIN, PRESSURE, SWELLING, DIFFICULTY VOIDING URINE, CONTINUED INCONTINENCE, DISCHARGE, SCARRING, INFECTION, ODOR, BLEEDING AND EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES, INCLUDING A MESH EXCISION SURGERY ON (B)(6) 2012, AT WHICH TIME ANOTHER MESH WAS USED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO EXTRUSION. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. (B)(4). 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 2210968-2012-02341. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE ON (B)(6) 2010 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, PRESSURE, SWELLING, DIFFICULTY VOIDING URINE, CONTINUED INCONTINENCE, DISCHARGE, SCARRING, INFECTION, ODOR, BLEEDING AND EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES, INCLUDING A MESH EXCISION SURGERY ON (B)(6) 2012, AT WHICH TIME ANOTHER MES WAS USED.. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3405499

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention