BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2801311 · Received October 23, 2012

    Report

    Report Number
    2210968-2012-06821
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ETHICON INC
    Product Code
    OTP
    PMA / PMN Number
    K071512
    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). ADDITIONAL NARRATIVE: IT WAS REPORTED THAT MESH WAS REPAIRED IN (B)(6) 2006. IT WAS REPORTED ON (B)(6) 2011 DUE TO RECURRENT URINARY TRACT INFECTION'S, STRESS URINARY INCONTINENCE, AND PAIN, THE PATIENT UNDERWENT A "SLING OPERATION", AUTOLOGOUS PUBOVAGINAL SLING AND URETHROLYSIS. NO ADDITIONAL INFORMATION PROVIDED AT THIS TIME.

    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. 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 2210968-2012-06824 AND 2210968-2012-06825. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SLING IMPLANTATION CONCURRENT WITH OPEN LAPAROSCOPY WITH BILATERAL SALPINGO-OOPHORECTOMY TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. THE PATIENT UNDERWENT PARTIAL MESH REMOVAL ON 10/04/2010 DUE TO EXPOSURE WITH BLEEDING, DYSPAREUNIA AND BLADDER SPASMS. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A MESH WAS IMPLANTED; CONCURRENTLY WITH OPEN LAPAROSCOPY WITH BSO. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES. THE PATIENT HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. IT WAS REPORTED THAT MESH WAS REPAIRED IN (B)(6) 2006. IT WAS REPORTED ON (B)(6) 2011 DUE TO RECURRENT URINARY TRACT INFECTION¿S, STRESS URINARY INCONTINENCE, AND PAIN, THE PATIENT UNDERWENT A ¿SLING OPERATION¿, AUTOLOGOUS PUBOVAGINAL SLING AND URETHROLYSIS WAS REPORTED THAT THE PATIENT UNDERWENT SLING IMPLANTATION CONCURRENT WITH OPEN LAPAROSCOPY WITH BILATERAL SALPINGO-OOPHORECTOMY TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE. THE PATIENT UNDERWENT PARTIAL MESH REMOVAL ON (B)(6) 2010 DUE TO EXPOSURE WITH BLEEDING, DYSPAREUNIA AND BLADDER SPASMS. IT WAS REPORTED THAT THE PATIENT EXPERIENCED PELVIC PAIN, PAINFUL INTERCOURSE, INFECTIONS AND BLADDER SPASMS. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND (B)(6) 2006 AND A MESH WAS IMPLANTED. IT WAS NOT CLARIFIED REGARDING WHICH DATE THE DEVICE WAS IMPLANTED ON. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES. THE PATIENT HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. 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 OTP ETHICON INC NA 1378278

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention