BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2850761 · Received November 29, 2012

    Report

    Report Number
    2210968-2012-07593
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 9, 2012
    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). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH ANTERIOR COLPORRHAPHY, CYSTOSCOPY, AND EXCISION OF PERIANAL SKIN LESION DUE TO CYSTOCELE, SUI, AND PERIANAL SKIN LESION. THE PATIENT EXPERIENCED PAIN, BLEEDING, INFECTION, URINARY PROBLEMS, AND DYSPAREUNIA. ON (B)(6) 2008, THE PATIENT UNDERWENT MESH REVISION SURGERY DUE TO SEVERE PAIN AND WORSENING INCONTINENCE.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSVAGINAL URETHRAL DIVERTICULECTOMY, TRANSVAGINAL SLING REVISION, CYSTOSCOPY AND CYSTOURETHROSCOPY X2 ON (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: IT WAS REPORTED THE PATIENT UNDERWENT SLING IMPLANTATION TO TREAT STRESS URINARY INCONTINENCE. AFTER IMPLANTATION THE PATIENT EXPERIENCED PAIN, INFECTION, BLEEDING, DYSPAREUNIA AND URINARY PROBLEMS. THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2008 DUE TO PAIN AND WORSENING INCONTINENCE. AS PER OPERATIVE REPORT, THE PATIENT HAD A REVISION AND REMOVAL OF SLING MATERIAL ON (B)(6) 2008. (B)(4) - DYSPAREUNIA; URINARY PROBLEMS. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TRANSVAGINAL URETHRAL DIVERTICULECTOMY, TRANSVAGINAL SLING REVISION, CYSTOSCOPY AND CYSTOURETHROSCOPY X2 ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 3009052

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention