BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3092395 · Received May 3, 2013

    Report

    Report Number
    2210968-2013-04949
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    PAH
    PMA / PMN Number
    K052401
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ODOR. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-03171. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT EXPERIENCED ¿MARKED HYDRONEPHROSIS PROBABLY SECONDARY TO PREVIOUS GYNECOLOGICAL PROCEDURE¿ [(B)(6) 2007]. HER PRE-OPERATIVE DIAGNOSIS WAS LEFT URETERAL STRICTURE AND THE PATIENT UNDERWENT LEFT URETERAL REIMPLANT [POLITANO-LEADBETTER REIMPLANT] ON (B)(6) 2008. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    DATE SENT TO FDA: 11/11/2016.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2007 TO TREAT STRESS URINARY INCONTINENCE AND PELVIC ORGAN PROLAPSE AND MESH AND A (BARD) PELVICOL WERE IMPLANTED INTO THE PATIENT. THE PATIENT CONCURRENTLY HAD A LAPAROTOMY, HYSTERECTOMY WITH A BILATERAL SALPINGOOPHORECTOMY AND VAULT SUSPENSION, SACROCOLPOPEXY, LATERAL VAGINAL WALL REPAIR, CULDOPLASTY AND ANTERIOR AND POSTERIOR REPAIR AND CYSTOSCOPY THE PATIENT EXPERIENCED PAIN, DISCOMFORT, PRESSURE, SWELLING, DIFFICULTY VOIDING URINE, CONTINUED INCONTINENCE, DISCHARGE, SCARRING, INFECTION, ODOR, AND BLEEDING. EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES, AND SHE HAS UNDERGONE ADDITIONAL SURGERIES AND REVISIONARY PROCEDURES, INCLUDING A MESH EXCISION SURGERY ON (B)(6) 2008. NO ADDITIONAL INFORMATION IS PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195243 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC PAH ETHICON, INC. NA 2983600

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention