BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1981829 · Received February 1, 2011

    Report

    Report Number
    2210968-2011-00084
    Event Type
    Injury
    Date Received
    February 1, 2011
    Report Date
    January 1, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (ILEUS), (NASOGASTRIC SUCTION). (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 THAT A PATIENT UNDERWENT AN UNEVENTFUL ENDOMETRIAL THERMAL ABLATION PROCEDURE IN (B)(6) 2010. THIRTEEN DAYS LATER, THE PATIENT DEVELOPED NAUSEA AND VOMITING. THE PATIENT WAS HOSPITALIZED BY HER FAMILY PRACTICE DOCTOR AND WAS FOUND TO HAVE AN ILEUS WHICH RESOLVED WITH NASOGASTRIC SUCTION OVER THREE DAYS. THE PATIENT IS NOW HOME AND DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention