BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2970121 · Received February 20, 2013

    Report

    Report Number
    2210968-2013-01486
    Event Type
    Injury
    Date Received
    February 20, 2013
    Report Date
    January 28, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT UNDERWENT MESH IMPLANTATION CONCURRENTLY WITH PLACEMENT OF SURGISIS SOFT TISSUE GRAFT (COOK MEDICAL) DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT POST IMPLANTATION PATIENT EXPERIENCED PAIN, INFECTION, BLEEDING AND URINARY, BOWEL AND NEUROMUSCULAR PROBLEMS. IT WAS REPORTED THAT PATIENT UNDERWENT MESH REMOVAL, CYSTOSCOPY, URETHROLYSIS AND BILATERAL DEFLUX INJECTION ON (B)(6) 2007 TO TREAT BLADDER OUTLET OBSTRUCTION. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2013 (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) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY AND TRANSURETHRAL RESECTION OF BLADDER TUMOR ON (B)(6) 2006 DUE TO RECURRENT GROSS HEMATURIA AND PRIOR HISTORY OF CYTOXAN FOR NON-HODGKINS LYMPHOMA WITH ABNORMALITY NOTED ON RECENT CYSTOSCOPY. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 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
    73079 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1224293

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SURGISIS SOFT TISSUE GRAFT