BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT

    MDR report key: 3915359 · Received July 7, 2014

    Report

    Report Number
    2210968-2014-08673
    Event Type
    Injury
    Date Received
    July 7, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K974098
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON (B)(6) 2014 TO TREAT MIXED URINARY INCONTINENCE AND OVERACTIVE BLADDER. AT AN UNSPECIFIED TIME POST PROCEDURE, THE PATIENT¿S PARTNER FELT A HARD STRUCTURE DURING SEX. THE PATIENT EXPERIENCED A MIDLINE EXPOSURE OF THE MESH LESS THAN 1 CM DETECTED BY THE REPORTING PHYSICIAN ON (B)(6) 2014. THE PATIENT WAS PRESCRIBED LOCAL ESTROGENS TO PROMOTE HEALING AND WAS REEXAMINED ON (B)(6) 2014. UPON FOLLOW UP, THE EXPOSURE WAS FOUND TO BE SMALLER AT ONLY 3-4 MM. AT THAT TIME, THE PATIENT VOIDED 450MLS ON UROFLOWMETRY AND HAD NO POST-VOID RESIDUALS. THE SURGEON OPINED THAT HER STRESS LEAKS ARE CURED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SLING PROCEDURE ON AN UNKNOWN DATE. THE PATIENT EXPERIENCED A LESS THAN 1 CM MIDLINE EXPOSURE OF THE MESH. THE PATIENT WAS PRESCRIBED LOCAL ESTROGENS TO PROMOTE HEALING. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394642 GYNECARE TVT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention POLYSORB SUTURES