BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3240844 · Received July 22, 2013

    Report

    Report Number
    2210968-2013-13987
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    October 18, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE CONCURRENTLY WITH CYSTOSCOPY ON (B)(6) 2001 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT ENDOMETRIAL ABLATION ON (B)(6) 2008.

    Additional Manufacturer Narrative · 1

    (B)(4). DYSPAREUNIA; URINARY PROBLEMS. ADDITIONAL NARRATIVE: IT WAS REPORTED THAT MESH WAS IMPLANTED DUE TO STRESS URINARY INCONTINENCE. POST IMPLANTATION PATIENT EXPERIENCED PAIN, INFECTION, FISTULA, BLEEDING, DYSPAREUNIA AND URINARY PROBLEMS.

    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

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2001 AND A MESH WAS IMPLANTED. IT WAS REPORTED THAT PATIENT UNDERWENT A CYSTOSCOPY TO RULE OUT EXTRUSION OF MESH (B)(6) 2002, NO EVIDENCE OF MESH EXTRUSION WHEN EXAMINED. ON (B)(6) 2008, THE PATIENT UNDERWENT REMOVAL OF OVARIAN CYST. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2001 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT SHE EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341358 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. UNK 824127

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention