BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3130158 · Received May 24, 2013

    Report

    Report Number
    2210968-2013-05898
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 3, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    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): 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE, VAGINAL PROLAPSE AND PELVIC PAIN. THE PATIENT EXPERIENCED PAIN, RECURRENCE OF INCONTINENCE, VAGINAL AND PELVIC PAIN, URINARY PROBLEMS, PAIN DURING INTERCOURSE, GENERAL ABDOMINAL PAIN, EROSION, INFECTION, VAGINAL SCARRING, INFLAMMATION, LYSIS OF ADHESIONS, LEFT URETER INJURY, HYDRONEPHROSIS, BAD LOWER BACK PAIN, DISCHARGE, INCONTINENCE, BLEEDING, AND BAD ODORS. IT WAS REPORTED THE PATIENT UNDERWENT BIRCH COLPOSUSPENSION , CYSTOSCOPY ON (B)(6) 2001, CYSTOSCOPY, LEFT RETROGRADE PYELOGRAM, INSERTION OF DOUBLE J STENT, URETEROSCOPY AND STONE MANIPULATION ON (B)(6) 2001, CYSTOSCOPY AND URETHRAL DILATION ON (B)(6) 2003, LEFT URETERONEOCYSTOSTOMY DUE TO LEFT URETER OBSTRUCTION SECONDARY TO FIBROSIS, LEFT URETEROCYSTOSTOMY WITH PSOAS HITCH, LYSIS OF INTRA ABDOMINAL ADHESION AND UREOLYSIS ON (B)(6) 2002. IT WAS REPORTED THAT THE PATIENT UNDERWENT BLADDER MESH/SLING REVISION ON (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2002 AND MESH WAS IMPLANTED INTO THE PATIENT. IT IS REPORTED THAT THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, 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
    230906 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON, INC. NA 914643

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention