BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 2131542 · Received June 16, 2011

    Report

    Report Number
    2210968-2011-00783
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    June 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ETHICON
    Product Code
    MNB
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2011-00767. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A THERMAL ABLATION PROCEDURE ON (B)(6) 2011. DURING THE PROCEDURE, THE BALLOON HAD FLUCTUATING PRESSURE AND TEMPERATURE AND THE MACHINE STOPPED AFTER FOUR MINUTES, HOWEVER THE PROCEDURE WAS COMPLETED. THERE WAS NO FLUID DEFICIT OR HOLE NOTED IN THE BALLOON. THE PATIENT RETURNED TO THE OFFICE ON (B)(6) 2011 WITH A FEVER OF 101 DEGREES F. ONE EXAM, THE PATIENT AND (B)(6) UTERUS WAS SLIGHTLY TENDER. THE PATIENT WAS DIAGNOSED WITH AN INFECTION AND PRESCRIBED DOXYCYCLINE 100MG FOR TEN DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER,BALLOON,TRANSCERVICAL MNB ETHICON NA DCMG78

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention