BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3213877 · Received July 9, 2013

    Report

    Report Number
    2210968-2013-12647
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    September 21, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    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 TRIMMING OF MESH ON (B)(6) 2005, DUE TO PROTRUSION OF MESH. ON (B)(6) 2007, EXCISION OF FOREIGN BODY WITH DEBRIDEMENT OF VAGINAL TISSUE WAS PERFORMED. MESH REMOVAL SURGERY WAS PERFORMED ON 05/23/2013 DUE TO EXTRUSION OF VAGINAL MESH WITH BLEEDING. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE CONCURRENTLY WITH BILATERAL UTEROSACRAL/SACROSPINOUS VAULT SUSPENSION ON (B)(6) 2004 DUE TO PELVIC RELAXATION AND SUI, VOIDING DYSFUNCTION AND MESH WERE IMPLANTED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT HYSTERECTOMY AND BSO ON (B)(6) 2006. NO ADDITIONAL INFORMATION PROVIDED.

    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.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2004 AND MESH WERE 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
    313248 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTN ETHICON INC. 1146532

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention