BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2772172 · Received October 4, 2012

    Report

    Report Number
    2210968-2012-05852
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 20, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS IMPLANTED DUE TO SUI AND HYPERMOBILITY OF URETHRA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4) ¿ URINARY PROBLEMS; UNDEFINED RECURRENCE; DYSPAREUNIA. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE WITH HYPERMOBILITY OF URETHRA. FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, BLEEDING, INFECTION, URINARY PROBLEMS, RECURRENCE AND DYSPAREUNIA. IT WAS REPORTED THAT ON (B)(6) 2010, DUE TO RECURRENT STRESS URINARY INCONTINENCE THE PATIENT UNDERWENT MESH IMPLANTATION. IT WAS FURTHER REPORTED THAT PATIENT UNDERWENT CYSTOSCOPY WITH HYDRODISTENTION, AND REVISION OF VAGINAL SLING ON (B)(6) 2009 DUE TO PELVIC PAIN, AND EROSION OF SLING. 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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED. SEE ALSO MEDWATCH 2210968-2012-05854. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2009 FOR PELVIC PAIN AND EROSION OF SLING. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION AND CYSTOSCOPY ON (B)(6) 2010 FOR RECURRENT STRESS URINARY INCONTINENCE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND MESH WAS USED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND AN UNKNOWN TRANSVAGINAL SURGICAL MESH POLYPROPYLENE DEVICE WAS USED. 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
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 2951153

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention