BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2980983 · Received February 27, 2013

    Report

    Report Number
    2210968-2013-01859
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE IN ORDER TO TREAT STRESS URINARY INCONTINENCE AND MESH WAS IMPLANTED. IT WAS REPORTED THAT FOLLOWING INSERTION OF THE MESH THE PATIENT EXPERIENCED PAIN, EROSION, EXTRUSION, INFECTION, URINARY/BOWEL PROBLEMS, ORGAN PERFORATION, FISTULAE, RECURRENCE, BLEEDING, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY AND A VAGINAL EXPLORATION WITH EXCISION OF MESH ON (B)(6) 2006 DUE TO EXPOSED MESH, AND RECURRENT URINARY TRACT INFECTIONS. THE PATIENT UNDERWENT CYSTOSCOPY AND EXCISION OF EXPOSED MESH AND FULGURATION ON (B)(6) 2009 FOR HEMATURIA AND BLADDER LESION, EROSION OF SLING INTO THE BLADDER. THE PATIENT ALSO UNDERWENT CYSTOSCOPY, EXCISION OF BLADDER FOREIGN BODY, BLADDER BIOPSY AND FULGURATION, AND TRANSURETHRAL COLLAGEN INJECTION ON (B)(6) 2009 DUE TO BLADDER FOREIGN BODY, BLADDER LESION AND STRESS URINARY INCONTINENCE. (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

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT TAKEDOWN OF FISTULA BETWEEN THE ILEUM AND URINARY BLADDER, SEGMENTAL ILEAL RESECTION, RECONSTRUCTION OF URINARY BLADDER, DEBRIDEMENT AND LAYERED CLOSURE OF URINARY BLADDER, AND CREATION OF OMENTAL PEDICLE ON (B)(6) 2008 DUE TO SMALL BOWEL OBSTRUCTION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND A SLING WAS IMPLANTED. 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
    83425 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1081414

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention