BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMACHOICE

    MDR report key: 1945250 · Received December 10, 2010

    Report

    Report Number
    2210968-2010-01670
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    October 15, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B)(6)2010. DURING THE PROCEDURE, PRESSURE LOSS OCCURRED SLOWLY AND THE DEVICE WAS NOTED TO HAVE A HOLE IN THE BALLOON. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PT CONSEQUENCES NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA CEMG05

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK