BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2882816 · Received December 20, 2012

    Report

    Report Number
    2210968-2012-08203
    Event Type
    Injury
    Date Received
    December 20, 2012
    Report Date
    December 2, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    FTL
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CYSTOSCOPY EXAM UNDER ANESTHESIA, DEBRIDEMENT OF VAGINAL WALL ABSCESS AND EXCISION OF MESH ON (B)(6) 2011, DUE TO PELVIC PAIN AND HISTORY OF MESH EROSION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH A DIAGNOSTIC LAPAROSCOPY WITH EXCISION OF THE RIGHT SIDED MASS, RIGHT SALPINGO-OOPHORECTOMY, AND LYSIS OF LESIONS.

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 06/13/2016. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, UNCONTROLLED LOSS OF URINE AND PAIN WITH INTERCOURSE. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    RESUBMISSION WITH THE CORRECT FILE NUMBER. IT WAS REPORTED THAT PATIENT UNDERWENT EXPOSURE OF MESH ON (B)(6) 2009 BY DR. (B)(6) AT (B)(6) DUE TO EXPOSURE OF MESH.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY PROBLEMS, ORGAN PERFORATION, FISTULAE, BLEEDING, DYSPAREUNIA AND VAGINAL SCARRING. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT EXCISION IN (B)(6) 2008 DUE TO EXTRUSION. IT WAS REPORTED THAT THE PATIENT UNDERWENT FURTHER MESH EXCISION ON (B)(6) 2011 DUE TO EXTRUSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2008, THE PATIENT OBSERVED RIGHT OVARY OUT DUE TO CANCEROUS AND HAD SLING AT THE SAME TIME AND HAS NOT FELT RIGHT SINCE. ON (B)(6) 2008, THE PATIENT UNDERWENT REVISION DUE TO EXPOSED MESH, REPAIR OF VAGINA AND SYNTHETIC SLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY FREQUENCY, UNCONTROLLED LOSS OF URINE AND PAIN WITH INTERCOURSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT EXPOSURE OF MESH ON (B)(6) 2009 BY DR. (B)(6) AT (B)(6) DUE TO EXPOSURE OF MESH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC FTL ETHICON, INC. NA 3017495

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention