BEUDAMED
    FDA Adverse Event Other Summary report: N

    ASPIRE PLATFORM

    MDR report key: 1378354 · Received April 15, 2009

    Report

    Report Number
    1223483-2009-00002
    Event Type
    Other
    Date Received
    April 15, 2009
    Date of Event
    February 25, 2009
    Report Date
    April 15, 2009
    Manufacturer
    PALOMAR MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEX
    PMA / PMN Number
    083165
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM WAS INSPECTED PRIOR TO THIS COMPLAINT AND WAS OPERATING WITHIN ITS SPECIFICATIONS AT THE TIME OF RELEASE. AT THE TIME THIS PATIENT WAS TREATED, THE DEVICE PERFORMED AS INTENDED WITH NO ISSUES REPORTED AND TREATMENT WAS UNEVENTFUL. THIS PATIENT WAS TREATED WITH A DEMONSTRATION SYSTEM AND NO REPORTS OF PRODUCT ISSUES/MALFUNCTIONS HAVE BEEN REPORTED WITH THAT SYSTEM SINCE THIS INCIDENT. ADDITIONALLY, THE SYSTEM HAS BEEN USED IN MULTIPLE TREATMENTS BY VARIOUS PHYSICIANS WITHOUT ANY ISSUES/MALFUNCTIONS.

    Description of Event or Problem · 1

    PATIENT WAS TREATED IN THE TRICEP AREA WITH THE DEVICE. PROCEDURE WAS UNEVENTFUL AND DEVICE PERFORMED AS INTENDED, WITH NO DEVICE ISSUES REPORTED. THE NEXT DAY, THE PATIENT PRESENTED WITH SEVERE SWELLING IN HER RIGHT ARM AND NUMBNESS IN HER FINGERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPIRE PLATFORM GEX PALOMAR MEDICAL TECHNOLOGIES, INC. 03-0032

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Disability ANESTHESIA