BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMATRX OFFICE THERMO THERAPY SYSTEM

    MDR report key: 2052444 · Received March 15, 2011

    Report

    Report Number
    2183959-2011-00107
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 11, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERMATRX CATHETER WAS RETURNED AND ANALYZED. THE CATHETER WAS RATED "UNDETERMINED." SIX HOLES IN THE CATHETER BALLOON APPEAR TO BE THE RESULT OF A SHARP INSTRUMENT. SOME OF THE HOLES PENETRATED THROUGH THE BALLOON AND THE CATHETER BODY. FURTHER INVESTIGATION WITH THIS CATHETER IS CURRENTLY IN PROCESS. WHEN ADD'L INFO IS AVAILABLE, A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS STATED THAT A THERMATRX CATHETER BALLOON BURST (DEFLATED) DURING A PROCEDURE ON (B)(6) 2011. THE CATHETER USED INITIALLY IN THE PROCEDURE BURST; A SECOND CATHETER WAS USED AND TREATMENT WAS SUCCESSFULLY COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERMATRX OFFICE THERMO THERAPY SYSTEM TRANSURETHRAL MICROWAVE THERMOTHERAPY SYSTEM MEQ AMERICAN MEDICAL SYSTEMS, INC. TMX-3000

    Patients

    Seq Age Sex Outcome Treatment
    1