BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPIRE PLATFORM

    MDR report key: 2314535 · Received October 21, 2011

    Report

    Report Number
    1223483-2011-00001
    Event Type
    Injury
    Date Received
    October 21, 2011
    Date of Event
    January 1, 2010
    Report Date
    October 21, 2011
    Manufacturer
    PALOMAR MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEX
    PMA / PMN Number
    080567
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF DEVICE INSTALLATION THE DISTRIBUTOR CONFIRMED BOTH DEVICES WERE WORKING WITHIN SPECIFICATIONS. ADDITIONALLY, (B)(6) POST INSTALLATION THE DISTRIBUTOR ALSO VERIFIED BOTH DEVICES WERE OPERATING WITHIN SPECIFICATIONS. BOTH DEVICE FACILITIES AS WELL AS THE TREATING PHYSICIAN BELIEVE THE DEVICES OPERATED AS INTENDED OVER THE COURSE OF THE YEAR. AFTER REVIEWING SEVERAL OF THE CASES WITH PHYSICIANS TRAINED IN PLASTIC SURGERY, IT WAS BELIEVED THESE INCIDENTS OCCURRED AS A RESULT OF POOR SUCTION TECHNIQUE AND WERE UNRELATED TO THE LASER SYSTEM. THE PHYSICIAN IS NO LONGER USING THESE DEVICES. ACCORDING TO THE USER FACILITIES NONE OF THE PATIENTS WERE HOSPITALIZED AND DID NOT EXPERIENCE INFECTION. PATIENT'S SKIN DISCOLORATION IS IMPROVING POST PEELS AND MICRODERM ABRASION. SCARRING IS ALSO IMPROVING WITH SILICONE PAD APPLICATIONS.

    Description of Event or Problem · 1

    OVER THE COURSE OF A YEAR MULTIPLE PATIENTS WERE TREATED BY THE SAME PHYSICIAN IN (B)(6). COMPLICATIONS WERE REPORTED BETWEEN TWO DIFFERENT LOCATIONS EACH HAVING THEIR OWN DEVICE. REPORTED COMPLICATIONS INCLUDED: POOR RESULTS AND CONTOUR DEFORMITIES IN APPROXIMATELY 35 PATIENTS. NECROSIS AND SCARRING IN APPROXIMATELY 10-15 PATIENTS. SKIN COLOR CHANGES IN APPROXIMATELY 20-30 PATIENTS AND ONE PATIENT EXPERIENCED BURN. BOTH DEVICES OPERATED WITHIN SPECIFICATION AND PERFORMED AS INTENDED. WITH THE EXCEPTION OF THE BURN, POOR SUCTION TECHNIQUE POST LASER TREATMENT IS THOUGHT TO BE THE CAUSE OF COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPIRE PLATFORM GEX PALOMAR MEDICAL TECHNOLOGIES, INC. 0300-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other TUMESCENT/ANESTHESIA