BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLIFT PELVIC FLOOR REPAIR

    MDR report key: 2772250 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-06093
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTP
    PMA / PMN Number
    K013718
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF EXPOSED INTRAVESICAL MESH ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4) .

    Additional Manufacturer Narrative · 1

    LAWYER-FILED REPORT 2210968-2012-06093-6 . IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH, THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, NEUROMUSCULAR PROBLEMS AND ORGAN PERFORATION. IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT MESH REMOVAL AND BLADDER REPAIR DUE TO EXPOSED MESH AND A HOLE IN THE BLADDER. (B)(4). THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-06094. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. PATIENT (B)(4) - DYSPAREUNIA, (B)(4) - RECURRENT PROLAPSE, (B)(4) MESH CONTRACTION, (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 2210968-2012-06094. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT BLADDER PROLAPSE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO TREAT CYSTOCELE, ENTEROCELE, RECTOCELE AND STRESS URINARY INCONTINENCE ON (B)(6) 2006 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL SURGERY ON (B)(6) 2011 DUE TO MESH EROSION INTO BLADDER.

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTION, NOCTURIA, URINARY FREQUENCY, SOME BURNING ON URINATION URGENCY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2006 AND MESH WAS USED. THE PATIENT EXPERIENCED MULTIPLE COMPLICATIONS, INCLUDING MESH CONTRACTION, PAIN, EROSION, FORMATION OF SCAR TISSUE, INFECTION, ORGAN PERFORATION, FISTULA, DYSPAREUNIA, NERVE DAMAGE, CHRONIC PELVIC PAIN, URINARY FECAL INCONTINENCE, AND RECURRENT PROLAPSE OF HER ORGANS REQUIRING ADDITIONAL SURGERIES. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    DETAILS: IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED RECURRENT URINARY TRACT INFECTION, NOCTURIA, URINARY FREQUENCY, SOME BURNING ON URINATION URGENCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROLIFT PELVIC FLOOR REPAIR MESH, SURGICAL, POLYMERIC OTP ETHICON, INC. NA 1362894

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention