BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3250684 · Received July 26, 2013

    Report

    Report Number
    2210968-2013-14782
    Event Type
    Injury
    Date Received
    July 26, 2013
    Report Date
    July 12, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2003 AND MESH WAS IMPLANTED CONCURRENTLY WITH CYSTOSCOPY AND CATHETERIZATION OF BLADDER; DUE TO TYPE 3 STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EROSION, INFECTION, URINARY/BOWEL PROBLEMS, FISTULAE, RECURRENCE, DYSPAREUNIA, AND VAGINAL SCARRING. IT WAS REPORTED THAT THE PATIENT UNDERWENT ROBOTIC-ASSISTED SACRAL COLPOPEXY, POSTERIOR COLPORRHAPHY, AND PERINEOPLASTY. THE PATIENT ALSO HAD MESH RESTORELLE Y IMPLANTED ON (B)(6) 2012 DUE TO VAGINAL VAULT PROLAPSE WITH STAGE III CYSTOCELE, STAGE II RECTOCELE AND RELAXED PERINEUM. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 09/24/2015, ADDITIONAL NARRATIVE: IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WAS IMPLANTED ALONG WITH CONCURRENT TVH. IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL TEMPORARY INTERSTIM LEAD PLACEMENT ON (B)(6) 2014 DUE TO RETENTION OF URINE. IT WAS REPORTED THAT THE PATIENT UNDERWENT SECOND STAGE INTERSTIM IMPLANT WITH VAGINAL EXPLORATION AND EXCISION OF VAGINAL FOREIGN BODY ON (B)(6) 2014 DUE TO URINARY RETENTION AND VAGINAL FOREIGN BODY. (B)(4).

    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.

    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 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
    350504 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 982065

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention