BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2872745 · Received December 13, 2012

    Report

    Report Number
    2210968-2012-08180
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 24, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    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 EXPERIENCED NERVE PAIN IN LEG, LEFT THIGH AND GROIN AND PERSISTENT URINARY TRACT INFECTIONS. (B)(4).

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE TO TREAT ANTERIOR PROLAPSE AND STRESS INCONTINENCE IN (B)(6) 2011 AND A SLING WAS IMPLANTED. THE PATIENT HAS EXPERIENCED PAIN, EROSION INTO THE URETHRA AND VAGINA INCLUDING DAMAGE TO THE URETHRA REQUIRING CORRECTIVE SURGERY. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. ON (B)(6) 2011, THE PATIENT UNDERWENT INCISION OF THE SLING IN THE LEFT FORNIX AND EXPLORATION OF THE LEFT FORNIX OUT TO THE OBTURATOR MEMBRANE. ON (B)(6) 2011, THE PATIENT UNDERWENT FURTHER SURGERY TO EXCISE THE TAPE. THE TAPE WAS INCISED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND A SLING WAS IMPLANTED. THE PATIENT HAS EXPERIENCED PAIN, EROSION INTO THE URETHRA AND VAGINA INCLUDING DAMAGE TO THE URETHRA REQUIRING CORRECTIVE SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3482964

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention