BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2772251 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-06094
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 21, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    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)(6).

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2012. PATIENT (B)(4) - DYSPAREUNIA, (B)(4) - RECURRENT PROLAPSE, 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 2210968-2012-06093. 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

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND A SLING WAS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (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

    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 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1289967

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention