BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3160037 · Received June 10, 2013

    Report

    Report Number
    2210968-2013-06901
    Event Type
    Injury
    Date Received
    June 10, 2013
    Report Date
    May 23, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION AND EXTRUSION. THE PATIENT UNDERWENT MESH REVISION/REMOVAL ON AN UNSPECIFIED DATE. IT WAS REPORTED THAT THE PATIENT HAD MESH IMPLANTED CONCURRENTLY WITH DILATION AND CURETTAGE IN 2011. THE PATIENT HAD A RIGHT OVARIAN CYST REMOVAL IN 2011. IT WAS REPORTED THAT THE PATIENT UNDERWENT MESH REVISION ON (B)(6) 2012 DUE TO EXPOSURE, PELVIC PAIN AND INTERSTITIAL CYSTITIS.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT MESH REVISION ON (B)(6) 2010 AND (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 AND MESH WAS IMPLANTED CONCURRENTLY WITH HYSTEROSCOPY, D&C, AND CYSTOSCOPY DUE TO SUI WITH HYPERMOBILE URETHRA AND MENORRHAGIA. IT WAS REPORTED THAT THE PATIENT UNDERWENT TVH WITH MESH IMPLANTATION AND CYSTOSCOPY ON (B)(6) 2013 DUE TO PELVIC PAIN, ABNORMAL UTERINE BLEEDING AND SUI. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2010 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
    260556 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 3222452

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention