BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2760489 · Received September 26, 2012

    Report

    Report Number
    2210968-2012-05564
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    September 4, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AFTER IMPLANTATION PATIENT EXPERIENCED INFECTION, VAGINAL SCARRING AND URINARY PROBLEMS. THE PATIENT UNDERWENT CYSTOSCOPY AND URETHRAL DILATATION ON (B)(6) 2005 BY THE IMPLANTING SURGEON, THERE IS NO EVIDENCE OF EROSION OR ANY ABNORMALITIES WITHIN THE BLADDER OR URETHRA. THE PATIENT UNDERWENT CYSTOSCOPY, PANDOSCOPY, BLADDER WASH CYSTOLOGY, BLADDER HYDRODISTENTION AND PELVIC EXAM ON (B)(6) 2010 DUE TO IRRITATIVE VOIDING SYMPTOMS AND UTI'S. FROM (B)(6) 2010, THE PATIENT HAD A HISTORY OF DYSURIA, IRRITATIVE VOIDING SYMPTOMS AND RECURRENT URINARY TRACT INFECTION'S AND NOW REQUIRES INTERMITTENT SELF CATHETERIZATION. HER PREVIOUS CAT SCANS IN (B)(6) 2009 AND (B)(6) 2010 SHOWED PERI-AORTIC LYMPH NODES SHE WAS REFERRED TO SURGICAL ONCOLOGIST. (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

    DATE SENT TO THE FDA: 08/12/2016. (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY RETENTION, URINARY URGENCY, FREQUENCY, AND PELVIC PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED HESITANCY, DYSURIA, INTERSTITIAL CYSTITIS, AND PYURIA.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION AND TAKEDOWN OF MESH ON (B)(6) 2006 DUE TO URINARY RETENTION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED URINARY RETENTION, URINARY URGENCY, FREQUENCY, AND PELVIC PAIN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED HESITANCY, DYSURIA, INTERSTITIAL CYSTITIS, AND PYURIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WAS USED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL TISSUES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 1129552

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention