BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERMATRX OFFICE THERMO THERAPY SYSTEM

    MDR report key: 2090513 · Received April 19, 2011

    Report

    Report Number
    2183959-2011-00137
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 6, 2011
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    MEQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERMATRX CATHETER WAS RETURNED AND ANALYZED. THE CATHETER WAS RATED "UNSATISFACTORY." THE CATHETER BALLOON WAS SPLIT AND STRETCHED. BALLOON APPEARS TO HAVE BEEN PUNCTURED BY A SHARP OBJECT. FURTHER INVESTIGATION WITH THIS CATHETER IS CURRENTLY IN PROCESS. WHEN ADDITIONAL INFO IS AVAILABLE, A F/U REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS STATED ON (B)(6) 2011 THAT RECENTLY, DATE NOT PROVIDED, A THERMATRX CATHETER COLLAPSED DURING TREATMENT. IT WAS STATED THAT THERE WAS NO INJURY TO THE PT.

    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.

    Patients

    Seq Age Sex Outcome Treatment
    1