BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT

    MDR report key: 3161866 · Received June 11, 2013

    Report

    Report Number
    2210968-2013-10049
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE AND MESH WERE IMPLANTED ON (B)(6) 2010 ALONG WITH CONCURRENT HYSTERECTOMY DUE TO SUI. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED, URINARY PROBLEMS, BLEEDING, AND DYSPAREUNIA. IT WAS REPORTED THAT PATIENT UNDERWENT ANOTHER IMPLANT WHICH WAS A AMS PRODUCT ON (B)(6) 2010. IT WAS REPORTED THAT PATIENT UNDERWENT A MESH IMPLANT AND PLACEMENT OF MIDURETHRAL SLING ON (B)(6) 2013. IT WAS REPORTED THAT PATIENT UNDERWENT A MESH REPAIR/PLACEMENT ON (B)(6) 2013. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGICAL PROCEDURES ON (B)(6) 2010 AND (B)(6) 2013 AND MESH AND AMS BIOARC 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
    263120 GYNECARE TVT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention AMS