BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMACHOICE

    MDR report key: 1810073 · Received August 12, 2010

    Report

    Report Number
    2210968-2010-00931
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 12, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    MKN
    PMA / PMN Number
    P970021
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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 PT UNDERWENT AN ENDOMETRIAL THERMAL ABLATION PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, IT WAS DISCOVERED THAT THE PT'S UTERUS WAS PERFORATED. THE PROCEDURE WAS ABORTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMACHOICE CATHETER, BALLOON, TRANSCERVICAL MKN ETHICON, INC. NA CCMG03

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention