BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT RETROPUBIC SYSTEM

    MDR report key: 3211676 · Received July 8, 2013

    Report

    Report Number
    2210968-2013-12453
    Event Type
    Injury
    Date Received
    July 8, 2013
    Report Date
    July 12, 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 AND MESH WAS IMPLANTED ALONG WITH CONCURRENT SIMPLE CYTOMETRY AND CYSTOSCOPY. IT WAS REPORTED THAT PATIENT UNDERWENT DIAGNOSTIC VIDEO LAPAROSCOPY, EXPLORATORY LAPAROTOMY, BILATERAL SALPINGO-OOPHOREOTOMY AND LYSIS OF ADHESIONS DUE TO RIGHT OVARIAN CYSTADENOFIBROMA, DIFFUSE ABDOMINAL PELVIC ADHESIVE DISEASE ON (B)(6) 2004.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND A MESH WAS IMPLANTED DUE TO SUI, URETHRAL HYPERMOBILITY, FREQUENCY OF URINATION & INTRINSIC SPHINCTER DEFICIENCY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND A MESH WAS IMPLANTED DUE TO SUI AND POP. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, INFECTION, URINARY/BOWEL PROBLEMS, RECURRENCE, NEUROMUSCULAR PROBLEMS AND VAGINAL SCARRING.

    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

    DATE SENT TO THE FDA: 08/04/2016.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 AND MESH WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2005 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
    309076 GYNECARE TVT RETROPUBIC SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 1336705

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention