BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3160236 · Received June 10, 2013

    Report

    Report Number
    2210968-2013-06917
    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). 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

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY DUE TO STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT PATIENT HAD AN EXCISION BIOPSY OF ABDOMINAL WALL MASS ON (B)(6) 2007. IT WAS REPORTED THAT PATIENT UNDERWENT URETHROLYSIS, SLING REVISION AND CYSTOSCOPY ON (B)(6) 2008 DUE TO VAGINAL WALL MESH EROSION. IT WAS REPORTED THAT PATIENT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY AND CHOLANGIOGRAM ON (B)(6) 2009.

    Additional Manufacturer Narrative · 1

    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 A MINIARC SLING IMPLANTATION ON (B)(6) 2013 DUE TO SUI AND CYSTOCELE GRADE 2. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2007 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT 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
    260740 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 2975448

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention