BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1881194 · Received October 20, 2010

    Report

    Report Number
    2210968-2010-01365
    Event Type
    Injury
    Date Received
    October 20, 2010
    Report Date
    September 20, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INFLAMMATION. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS REC'D, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON AN UNK DATE. THE PT WAS DOING WELL AFTER THE PROCEDURE, THEN DEVELOPED AN INFLAMED RIGHT TUBE. ADDITIONAL INFORMATION WAS REQUESTED.

    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