BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3081420 · Received April 26, 2013

    Report

    Report Number
    2210968-2013-04588
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 4, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT HAD IRREGULAR UTERINE BLEEDING AND ULTRASOUND SHOWED ENDOMETRIAL THICKENING, DILATION AND CURETTAGE HYSTEROSCOPY WERE DONE AND THE PATHOLOGY REPORT WAS NEGATIVE INITIALLY BUT LATER SHOWED ENDOMETRIAL CARCINOMA. THE PATIENT UNDERWENT TOTAL ABDOMINAL HYSTERECTOMY/ BILATERAL SALPINGO-OOPHORECTOMY AND TENSION FREE TAPE (UNKNOWN) DUE TO IRREGULAR BLEEDING AND STRESS URINARY INCONTINENCE ON (B)(6) 2004. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL/REVISION ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, BLEEDING, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING, FISTULAE AND ORGAN PERFORATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2012 DUE TO MESH EROSION WHICH CAUSED PELVIC PAIN AND DYSPAREUNIA. (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A CYSTOSCOPY DUE TO STRESS URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY TRACT INFECTION, MIXED URINARY INCONTINENCE, ATROPHIC VAGINITIS, URINARY FREQUENCY, DISCOMFORT AND VAGINAL BURNING.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URETHRAL OBSTRUCTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND A SLING WAS IMPLANTED.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
    183030 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 3365783

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention