BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL SR ERASER SSYTEM

    MDR report key: 3089454 · Received January 28, 2006

    Report

    Report Number
    2950711-2006-00002
    Event Type
    Injury
    Date Received
    January 28, 2006
    Date of Event
    November 16, 2005
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MFG RECORDS FOR THE SYS NOTED NO NON-CONFORMANCE RELATED TO THE EVENT. REPORTS FROM DR. STOVER, THE TREATING PHYSICIAN, GAVE NO INDICATION THAT SYS M0370 DID NOT PERFORM AS EXPECTED. HOWEVER, THE TREATMENT TIP WAS NOT AVAILABLE FOR INSPECTION.

    Description of Event or Problem · 1

    ON (B)(6) 2005, PT RECEIVED ONE TREATMENT WITH THE FRAXEL SR LASER SYSTEM AT A SETTING OF 1000 MTZ/CM2 AND 10MJ. TREATMENT WAS PERFORMED WHILE PT WAS UNDER IV SEDATION FOR CONCURRENT SURGICAL PROCEDURES. PHYSICIAN REPORTED AUDIBLE BEEPING SYSTEM FEEDBACK THROUGHOUT TREATMENT DUE TO RAPID HANDPIECE MOTION AND NOTED SOME PEELING WITHIN THE TREATED AREA IMMEDIATELY FOLLOWING TREATMENT. (B)(6) HOURS POST-TREATMENT ((B)(6) 2005), THE PHYSICIAN SUBSEQUENTLY REPORTED THAT THE PT DEVELOPED BURNS WITHIN THE TREATMENT AREA. THE PHYSICIAN (DR (B)(6)) REPORTED ON (B)(6) 2005 THAT HE ELECTED TO ADMINISTER A THERAPEUTIC REGIMEN IN ORDER TO MANAGE THE SYMPTOMS AND MINIMIZE THE POTENTIAL FOR PERMANENT SCARRING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other DURING THE FIRST FIVE WEEKS FOLLOWING TREATMENT.| TOPICAL OVER-THE COUNTER NEOSPORIN WAS APPLIED| PREVENT A SECONDARY INFECTION. IN ADDITION,| IMMEDIATELY FOLLOWING TREATMENT, THE PT WAS| INSTRUCTED TO APPLY OCCLUSIVE MOISTURIZING| OINTMENT IN ORDER TO MANAGE THE SYMPTOMS AND