BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3024183 · Received March 27, 2013

    Report

    Report Number
    2210968-2013-03068
    Event Type
    Injury
    Date Received
    March 27, 2013
    Report Date
    March 7, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): 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

    THE PATIENT UNDERWENT MESH IMPLANTATION CONCURRENTLY WITH HYSTERECTOMY ON (B)(6) 2010 DUE TO STRESS URINARY INCONTINENCE. FOLLOWING INSERTION, THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE AND DYSPAREUNIA. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH BILATERAL SALPINGECTOMY, ANTERIOR/POSTERIOR REPAIR WITH VAGINAL ENTEROCELE REPAIR, LAPAROSCOPIC UTEROSACRAL LIGAMENT SUSPENSION AND VAGINAL BIOPSY; DUE TO RECTOCELE AND CYSTOCELE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED VAGINAL SCARRING AND BURNING URINATION. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2013, ALONG WITH UTEROLYSIS DUE TO INFECTION, BLEEDING, SUI, RETENTION AND PAIN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH BILATERAL SALPINGO-OOPHORECTOMY, ANTERIOR AND POSTERIOR REPAIR WITH VAGINAL ENTEROCELE REPAIR, CYSTOSCOPY, AND VAGINAL BIOPSY, DUE TO RECTOCELE, CYSTOCELE, AND APICAL VAULT PROLPASE WITH ENTEROCELE AND 0.5 CENTIMETER LESION OF THE VAGINAL VAULT AT THE APEX.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND AN OBTURATOR 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
    126222 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 3379937

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention