BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT

    MDR report key: 5233810 · Received November 18, 2015

    Report

    Report Number
    2210968-2015-18672
    Event Type
    Injury
    Date Received
    November 18, 2015
    Date of Event
    October 29, 2015
    Report Date
    November 3, 2015
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADDITIONALLY PAIN AND DISCHARGE. THE PATIENT UNDERWENT A REMOVAL OF SUBURETHRAL SECTION OF MESH ON (B)(6) 2015. CURRENTLY, THE PATIENT IS FINE BUT STILL SOON AFTER SURGERY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SLING PROCEDURE ON AN UNKNOWN DATE. THE PATIENT EXPERIENCED MESH EROSION INTO THE VAGINA AND UNDERWENT REMOVAL OF MESH ON (B)(6) 2015. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764155 GYNECARE TVT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention