BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE TVT OBURATOR SYSTEM

    MDR report key: 3963967 · Received July 29, 2014

    Report

    Report Number
    2210968-2014-10253
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    June 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT SHE UNDERWENT AN OBTURATOR SLING PROCEDURE ON (B)(6) 2014. ON (B)(6) 2014, THE PATIENT DEVELOPED A FEVER OF 103.6 AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT STATED SHE WAS NEVER TOLD WHAT EXACTLY THE CAUSE OF THE FEVER WAS, BUT HAD BEEN REFERRED FOR "CELLULITES" AND THEN A BLOOD CLOT. THE PATIENT WAS TREATED WITH TWO TYPES OF ANTIBIOTICS. THE PATIENT STILL EXPERIENCES LEG AND GROIN PAIN. THE PATIENT DOES NOT EXPERIENCE A SENSATION WHEN SHE NEEDS TO URINATE AND IS STILL HAS INCONTINENCE WITH SNEEZING. THE PATIENT REQUESTED SLING REMOVAL TWO DAYS AFTERWARDS, WHILE IN THE HOSPITAL, BUT THE PHYSICIAN REFUSED TO AND TOLD HER THE SLING WAS FINE. THE PATIENT IS NOT ABLE TO FUNCTION AT THE SAME LEVEL AS PRIOR TO SURGERY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441258 GYNECARE TVT OBURATOR SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICAL OTN ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R