BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2945885 · Received February 6, 2013

    Report

    Report Number
    2210968-2013-00768
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED BOWEL PROBLEMS, RECURRENCE, AND VAGINAL SCARRING. IT WAS ALSO REPORTED THAT PATIENT UNDERWENT EXCISION OF EXTRUDED VAGINAL AND OBSTRUCTING MIDURETERAL SLING, AND CYSTOSCOPY ON (B)(6) 2010 DUE TO PELVIC AND VAGINAL PAIN, DYSPAREUNIA, INFECTION, URINARY INCONTINENCE, RETENTION, LEAKAGE, INFLAMMATION, AND VAGINAL BLEEDING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH IMPLANTATION DUE TO STRESS URINARY INCONTINENCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED INCONTINENCE, FREQUENCY AND INCOMPLETE BLADDER EMPTYING. IT WAS REPORTED THAT PATIENT UNDERWENT TOTAL VAGINAL HYSTERECTOMY AND BILATERAL SALPINGO-OOPHORECTOMY ON (B)(6) 2010 BY DR. (B)(6) DUE TO UTERINE FIBROIDS.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PATIENT CODES: (B)(4) - URGENCY, (B)(4) - OVERACTIVE BLADDER, NOCTURIA ADDITIONAL INFORMATION. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URGENCY, OVERACTIVE BLADDER, AND NOCTURIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH AND THE UPHOLD VAGINAL SUPPORT SYSTEM WERE USED. IT WAS REPORTED THAT SHE 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
    50651 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3398077

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention