BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2593952 · Received May 31, 2012

    Report

    Report Number
    2210968-2012-01924
    Event Type
    Injury
    Date Received
    May 31, 2012
    Report Date
    May 10, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, URINARY PROBLEMS, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF MESH ON (B)(6) 2010, EXCISION OF EXTRUDED MESH AND REPAIR OF VAGINAL WALL FLAP ON AN UNDISCLOSED DATE, AND EXCISION OF REMAINING EXTRUDED MESH ON AN UNDISCLOSED DATE. (B)(4).

    Additional Manufacturer Narrative · 1

    IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY INCONTINENCE, DYSPAREUNIA AND VAGINAL/BLADDER INFECTION. IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF EXTRUDED MESH ON (B)(6) 2010 BY DR. (B)(6), (B)(6) MEDICAL GROUP UROLOGY, (B)(6) AND ON (B)(6) 2012 IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF EXTRUDED MESH BY DR. (B)(6) AT UROGYNECOLOGY CONSULTANTS MEDICAL GROUP (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL SURGICAL PROCEDURE AND A MESH WAS IMPLANTED CONCURRENTLY WITH LAPAROSCOPIC BILATERAL TUBAL LIGATION. 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): DYSPAREUNIA. 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 A PATIENT UNDERWENT A SLING PROCEDURE TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE ON (B)(6) 2009. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE, AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES DURING (B)(6) 2010. SHE CONTINUED TO EXPERIENCE EROSION AND DYSPAREUNIA. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Description of Event or Problem · 1

    DETAILS: IT HAS BEEN REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY INCONTINENCE, DYSPAREUNIA AND VAGINAL/BLADDER INFECTION. DETAILS: IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF EXTRUDED MESH OV (B)(6) 2010 BY DR. (B)(6), (B)(6) MEDICAL GROUP UROLOGY, (B)(6) AND ON (B)(6) 2012 IT WAS REPORTED THAT THE PATIENT UNDERWENT EXCISION OF EXTRUDED MESH BY DR. (B)(6) AT UROGYNECOLOGY CONSULTANTS MEDICAL GROUP (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3233028

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention