BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3093476 · Received May 6, 2013

    Report

    Report Number
    2210968-2013-04975
    Event Type
    Injury
    Date Received
    May 6, 2013
    Report Date
    May 19, 2018
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH SACROCOLPOPEXY DUE TO PELVIC ORGAN PROLAPSE. THE PATIENT EXPERIENCED PAIN, EROSION, URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL OF MESH, EXPLORATORY AND A HYSTERECTOMY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION WITH TOTAL ABDOMINAL HYSTERECTOMY, COLPOPEXY, CYSTOSCOPY AND PROCTOSCOPY IN 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS IMPLANTED CONCURRENTLY WITH PROLITE MESH AND SACROCOLPOPEXY; DUE TO PELVIC ORGAN PROLAPSE. 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. THE PATIENT EXPERIENCED URINARY/BOWEL PROBLEMS, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL OF MESH, EXPLORATORY AND A HYSTERECTOMY ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION WITH TOTAL ABDOMINAL HYSTERECTOMY, COLPOPEXY, CYSTOSCOPY AND PROCTOSCOPY IN 2010. 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 PATIENT EXPERIENCED ADHESION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND MESH WAS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197173 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3211336

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention PROLITE MESH