BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3163364 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10168
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    July 11, 2016
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K012628
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL RIGHT VULVECTOMY FOR A GRADE 2 INTRAEPITHELIAL NEOPLASIA ON (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): REASON FOR SURGERY: CHRONIC PELVIC PAIN, ABNORMAL VAGINAL BLEEDING, SUICONCURRENT PROCEDURES: TAH/BSO, CYSTOSCOPYIT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED CHRONIC PELVIC AND VAGINAL AREA PAIN; CONTINUED URINARY INCONTINENCE AND RETENTION; RECURRENT VAGINAL AND URINARY TRACT INFECTIONS; SEVERE PAIN IN LEGS AND FEET; SPASMS THROUGHOUT BODY; LOWER ABDOMINAL SWELLING; RECTAL PAIN AND BLEEDING; RECURRENT CONSTIPATION; EMOTIONAL AND PSYCHOLOGICAL SUFFERING. NO ADDITIONAL INFORMATION WAS PROVIDED.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). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2008 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
    264670 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 3157220

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention