BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3042466 · Received April 9, 2013

    Report

    Report Number
    2210968-2013-03635
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY PROBLEMS, BOWEL PROBLEMS, RECURRENCE AND DYSPAREUNIA. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT SPECULUM EXAM UNDER ANESTHESIA, CYSTOSCOPY WITH HYDRODILATATION OF BLADDER, BLADDER BIOPSY X2 WITH FULGURATION, DILATION OF URETHRAL STRICTURE, AND BILATERAL RETROGRADE PYELOGRAMS ON (B)(6) 2008 DUE TO MICROSCOPIC HEMATURIA, VOIDING DYSFUNCTION, AND URETHRAL STRICTURE. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT CYSTOSCOPY AND TRANSVAGINAL URETHROLYSIS ON (B)(6) 2009 DUE TO BLADDER OUTLET OBSTRUCTION. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT: CYSTOSCOPY WITH CALIBRATION AND DILATATION OF URETHRAL STRICTURE, HYDRODISTENTION OF THE BLADDER, BLADDER BIOPSY TIMES 3 WITH FULGURATION, AND EXAMINATION UNDER ANESTHESIA ON (B)(6) 2010 DUE TO VOIDING DYSFUNCTION, INTERSTITIAL CYSTITIS, BLADDER LESIONS AND URETHRAL STRICTURE; CYSTOSCOPY, HYDRODISTENTION OF THE BLADDER, AND BLADDER BIOPSY X1 WITH FULGURATION AND DILATATION OF URETHRAL STRICTURE ON (B)(6) 2010 DUE TO BLADDER OUTLET OBSTRUCTION, URETHRAL STRICTURE, HEMORRHAGIC BLADDER LESIONS AND INTERSTITIAL CYSTITIS; HYDRODISTENTION OF THE BLADDER, BILATERAL RETROGRADE PYELOGRAMS, AND URETHRAL STRICTURE CALIBRATION AND DILATATION ON (B)(6) 2012 DUE TO INTERSTITIAL CYSTITIS, GROSS HEMATURIA, PELVIC PAIN AND URETHRAL STRICTURE DISEASE; CYSTOSCOPY, HYDRODISTENTION OF THE BLADDER, BLADDER BIOPSY X2 WITH FULGURATION, AND BILATERAL RETROGRADE PYELOGRAMS ON (B)(6) 2013 DUE TO INTERSTITIAL CYSTITIS, PELVIC PAIN, H/O URETHRAL STRICTURE DISEASE, MICROSCOPIC HEMATURIA, AND ANTERIOR BLADDER LESION; AND BILATERAL PERCUTANEOUS INTERSTIM SACRAL NEUROMODULATION TESTING AND CYSTOSCOPY WITH URETHRAL STRICTURE CALIBRATION AND DILATATION ON (B)(6) 2014 DUE TO URINARY URGENCY, FREQUENCY, URINARY URGE INCONTINENCE, AND RECURRENCE OF URETHRAL STRICTURE DISEASE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REMOVAL ON (B)(6) 2015 BY DR. (B)(6) , M.D.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 AND MESH 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
    145902 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3016683

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention