BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2931255 · Received January 28, 2013

    Report

    Report Number
    2210968-2013-00520
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 7, 2013
    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): IT WAS REPORTED THAT THE PATIENT HAD THE CONCURRENT PROCEDURES OF REPAIR OF BLADDER LACERATION AND CYSTOURETHROSCOPY PERFORMED DURING MESH IMPLANTATION.

    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 TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2013-00519. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT AFTER IMPLANTATION PATIENT EXPERIENCED PAIN, BURNING BLADDER PAIN, VAGINAL PAIN, PELVIC PAIN, BILATERAL HIP PAIN, LEFT LEG PAIN, PAIN WITH INTERCOURSE, URINARY INCONTINENCE, STRESS URINARY INCONTINENCE, BLOATING, FECAL INCONTINENCE, BLADDER INFECTIONS, URINARY TRACT INFECTIONS, VAGINAL DISCHARGE, INFLAMMATION. NO ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED PATIENT EXPERIENCED A LACERATION OF THE BLADDER WHICH WAS RECOGNIZED AND REPAIRED BY THE IMPLANTING SURGEON ON (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 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
    36536 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC FTL ETHICON, INC NA 3308687

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention