BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3122463 · Received May 21, 2013

    Report

    Report Number
    2210968-2013-05735
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    August 15, 2006
    Report Date
    April 30, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - FIBROMYALGIA; BLADDER PROBLEMS; INFECTION OCCURRED. 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

    RESUBMISSION WITH THE CORRECT FILE NUMBER. IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT THE SLING PROCEDURE ON (B)(6) 2006. THE PATIENT STATES, ¿SINCE THEN I HAVE BECOME SO ILL AND DISABLED, THAT I CAN NO LONGER WALK WITHOUT SEVERE PAIN AND AM IN CONSTANT PAIN. I HAD A PARTIAL TAPE REMOVAL ONE MONTH AGO, AND HAVE LAB REPORTS STATING THAT MY BODY WAS REJECTING THIS ERODING MESH. I HAVE FURTHER SURGERY PLANNED TO REMOVE MORE MESH, AS THE PAIN IS CRIPPLING.¿ SHE REPORTS THAT HER LIFE HAS BEEN RUINED BECAUSE OF HAVING A SLING INSERTED, ALONG WITH MY FAMILY LIFE. IF SHE WAS TOLD OF ANY OF THE SIDE EFFECTS, SHE NEVER WOULD HAVE UNDERWENT THE PROCEDURE. ADDITIONAL INFORMATION WAS REQUESTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT A SLING PROCEDURE. AS SOON AS THE SLING WAS IMPLANTED, THE PATIENT WAS IN CONSTANT PAIN, AND NEEDED FURTHER SURGERY THREE MONTHS LATER TO MAKE ADJUSTMENTS. OVER THE YEARS, THE PATIENT HAS EXPERIENCED CONSTANT URINARY TRACT INFECTIONS. SHE WAS DIAGNOSED WITH FIBROMYALGIA WITH A QUERY ON LUPUS. THE PATIENT TOOK CONSTANT PAIN MEDICATION AND CAN NO LONGER FUNCTION IN NORMAL LIFE. THE PATIENT STATED THAT SHE STILL HAD BLADDER PROBLEMS AND THAT THE SLING NEVER WORKED. THE PATIENT STATED SHE WAS TOLD THAT THE SLING SHOULD BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224667 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 2918356

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention