BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2971594 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01379
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE, MENORRHAGIA, RECURRENT CERVICAL INTRAEPITHELIAL NEOPLASIA, AND PERIMENOPAUSE. THE PATIENT UNDERWENT THE CONCURRENT PROCEDURES OF A TOTAL VAGINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY DURING MESH IMPLANTATION. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, NEUROMUSCULAR PROBLEMS¿MUSCLE WEAKNESS, AND VAGINAL SCARRING. THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2007, DUE TO MESH EXPOSURE, VAGINAL WALL MESH EROSION, PAINFUL SEXUAL INTERCOURSE, URINARY TRACT INFECTIONS, PELVIC PAIN AND VAGINAL BURNING SENSATION. THE PATIENT UNDERWENT A SECOND MESH REVISION ON (B)(6) 2007, DUE TO MESH EXPOSURE, URINARY TRACT INFECTIONS, PELVIC PAIN AND VAGINAL BURNING SENSATION. THE PATIENT UNDERWENT EXCISION OF MESH EROSION ON (B)(6) 2008, DUE TO MESH EROSION, URINARY RETENTION, URINARY TRACT INFECTIONS, PELVIC PAIN AND VAGINAL BURNING SENSATION. (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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. 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
    75874 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 2989994

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention