BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3140543 · Received May 31, 2013

    Report

    Report Number
    2210968-2013-06342
    Event Type
    Injury
    Date Received
    May 31, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    OTN
    PMA / PMN Number
    K03568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2011-01770. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2011- 01770. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    RESUBMISSION WITH THE CORRECT FILE NUMBER. DATE SENT TO THE FDA: 01/27/2017. IT WAS REPORTED THAT PATIENT UNDERWENT ANTERIOR REPAIR WITH AVAULTA SOLO GRAFT AND TVT SLING PROCEDURE- TRANSOBTURATOR APPROACH- ABBREVO WITH CYSTOSCOPY ON (B)(6) 2011 BY DR.(B)(6).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION PATIENT EXPERIENCED URINARY TRACT INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PELVIC FLOOR REPAIR PROCEDURE ON (B)(6) 2006 AND MESH WAS USED. THE PATIENT DEVELOPED RECTAL BLEEDING AND PELVIC PAIN DURING (B)(6) 2010. A LARGE AREA OF EROSION OF THE MESH INTO THE ANTERIOR PORTION OF THE RECTUM WAS DIAGNOSED ON (B)(6) 2010. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2010 FOR TRANSRECTAL EXCISION OF THE PELVIC MESH AND REPAIR OF A LARGE RECTOVAGINAL FISTULA. ON (B)(6) 2012, THE PATIENT HAD AN EXCISION OF MESH, REPAIR OF RECTOVAGINAL FISTULA AND ENTEROCELE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240889 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC NA 1361107

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention