BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPIRE PLATFORM

    MDR report key: 1353072 · Received March 30, 2009

    Report

    Report Number
    1223483-2009-00001
    Event Type
    Injury
    Date Received
    March 30, 2009
    Date of Event
    March 1, 2009
    Report Date
    March 30, 2009
    Manufacturer
    PALOMAR MEDICAL TECHNOLOGIES, INC.
    Product Code
    GEX
    PMA / PMN Number
    083165
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS TREATED IN THE ABDOMINAL REGION WITH THE DEVICE. PROCEDURE WAS UNEVENTFUL AND DEVICE PERFORMED AS INTENDED WITH NO DEVICE ISSUES. ONE DAY POST TREATMENT, PATIENT PRESENTED WITH ABDOMINAL PAIN AND UNDERWENT SURGERY. SURGEON LOCATED 3 PIN SIZE HOLES IN THE SMALL INTESTINE AND RESECTED INJURED TISSUE. PATIENT HAS RECOVERED FROM SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASPIRE PLATFORM GEX PALOMAR MEDICAL TECHNOLOGIES, INC. 03-0065

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention ANESTHESIA