BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 2972743 · Received February 21, 2013

    Report

    Report Number
    2210968-2013-01562
    Event Type
    Injury
    Date Received
    February 21, 2013
    Report Date
    February 5, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2011 AND MESH WAS IMPLANTED DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED LEFT LOWER QUADRANT PAIN, ABDOMINAL PAIN, HEMATURIA, URINE FREQUENCY, SEVERE URGENCY, URGE INCONTINENCE, PAIN WITH DELAYED VOIDING, SUPRAPUBIC DISCOMFORT, UNCOMFORTABLE FEELING AT THE VULVA, VAGINAL PAIN, RIGHT LOWER QUADRANT PAIN, SUI, GRANULATION AT THE RIGHT ANTERIOR FORNIX, AND MESH EROSION. IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT MESH EXCISION AND CYSTOSCOPY ON (B)(6) 2014 FOR MESH GRANULATION. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESUBMISSION WITH THE CORRECT FILE NUMBER. DATE SENT TO THE FDA: 01/19/2017 IT WAS REPORTED THAT PATIENT UNDERWENT MESH EXCISION AND CYSTOSCOPY ON (B)(6) 2014 (CORRECTION ON DATE PER OR REPORT) FOR TVT GRANULATION. PATIENT HAD CYSTOSCOPY ON (B)(6) 2012 BY (B)(6) FOR IRRITATIVE VOIDING SYMPTOMS POST TVT. PATIENT HAD CYSTOSCOPY BY DR. (B)(6) ON (B)(6) 2011 FOR RECENT HEMATURIA AND MILD CYSTITIS AND MODERATE SUI WITH BLADDER NECK PROLAPSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO TREAT STRESS URINARY INCONTINENCE ON (B)(6) 2011 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE CONTINUED TO EXPERIENCE PAIN, DYSPAREUNIA, 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
    77413 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 3515859

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention