BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3131637 · Received May 29, 2013

    Report

    Report Number
    2210968-2013-06046
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 9, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K100936
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO UTEROVAGINAL PROLAPSED AND MULTIPLE PELVIC FLOOR DEFECTS. THE PATIENT EXPERIENCED URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA AND VAGINAL SCARRING. BOSTON SCIENTIFIC REPIFORM AND BOSTON SCIENTIFIC REPIFORM (2) WERE IMPLANTED. LOT# B36516019 AND B36516021. IT WAS REPORTED THAT THE PATIENT UNDERWENT SUTURE REMOVAL ON (B)(6) 2011 DUE TO PAIN AND DISCOMFORT. (B)(4).

    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

    IT WAS REPORTED THAT PATIENT CONCURRENTLY UNDERWENT TOTAL VAGINAL HYSTERECTOMY, MCCALL CULDOPLASTY, CYSTOSCOPY, BILATERAL PARAVAGINAL DEFECT REPAIR, KELLY-KENNEDY PLICATION AUGMENTATION WITH GRAFT, BULLARD-WATSON RECONSTRUCTION OF THE PERINEAL BODY AUGMENTATION WITH GRAFT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH AND THE BOSTON SCIENTIFIC REPLIFORM (2) WERE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT CONCURRENTLY UNDERWENT TOTAL VAGINAL HYSTERECTOMY, MCCALL CULDOPLASTY, CYSTOSCOPY, BILATERAL PARAVAGINAL DEFECT REPAIR, KELLY-KENNEDY PLICATION AUGMENTATION WITH GRAFT, BULLARD-WATSON RECONSTRUCTION OF THE PERINEAL BODY AUGMENTATION WITH GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235170 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3470547

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention