BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL SR LASER SYSTEM

    MDR report key: 571677 · Received February 8, 2005

    Report

    Report Number
    2950711-2005-00001
    Event Type
    Injury
    Date Received
    February 8, 2005
    Date of Event
    September 17, 2004
    Report Date
    February 8, 2005
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT TREATMENTS WITH THE FRAXEL SR LASER SYSTEM. THE PHYSICIAN STATED THAT THE PT HAD BEEN TREATED WITH THE LASER SYSTEM (FIRST RELEASED VERSION). THE FOLLOWING TREATMENT (TREATMENT 2) WAS PERFORMED WITH THE SECOND VERSION OF THE LASER SYSTEM USING THE SAME ENERGY PARAMETERS (1OMJ/MTZ) BASED ON EXPERIENCE WITH THE FIRST VERSION OF THE DEVICE. THE PT TOLERATED THE TREATMENT 1 WITH "NO DIFFICULTY." WITH TREATMENT 2, THE PT HAD MARKED PAIN AND MARKED DISCOMFORT AS WELL AS MARKET PIN-POINT BLEEDING. FOLLOWING THE SECOND TREATMENT, THE PT REPORTED THAT THEY HAD A VERY DIFFICULT 10-DAY PERIOD OF HEALING DURING WHICH THEY EXPERIENCED SCABBING AND CRUSTING. THE PT FURTHER REPORTED THAT THEY HAD DEVELOPED AN INFECTION FOLLOWING TREATMENT THAT SUBSEQUENTLY EVOLVED INTO SCARRING, WHICH WAS CONFIRMED BY THE TREATING PHYSICIAN. ADDITIONAL FRAXEL TREATMENTS CONTINUED AT REDUCED ENERGICS USING THE SECOND VERSION OF THE DEVICE SET AT 6 TO 9MJ/MTZ. THE PT TOLERATED THE ADDITIONAL PROCEDURES WELL. THE PHYSICIAN STATED THAT THE ADDITIONAL TREATMENTS HELPED TO RESOLVE THE SCARRING TO SOME DEGREE, BUT THAT SCARRING IS STILL PRESENT AS OF THE PT'S LATEST VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL SR LASER SYSTEM SURGICAL LASER GEX RELIANT TECHNOLOGIES, INC. 00-00609 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention TREATMENT 1 (2004) - LASERCAINE, TEMOVATC CREAM| LASCREAINE, TEMOVATE CREAM.| (TOPICAL CORTICOSTERIOD), TREATMENT 2 (2004) -