BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRAXEL SR LASER SYSTEM

    MDR report key: 5483133 · Received August 12, 2005

    Report

    Report Number
    2950711-2005-00006
    Event Type
    Injury
    Date Received
    August 12, 2005
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR FRAXEL LASER SR SYSTEM WAS PERFORMED AS PART OF THE COMPLAINT INVESTIGATION. BASED ON THIS REVIEW, WE CONCLUDED THE DEVICE PERFORMED AS INTENDED. THEREFORE, RETURN OF THE LASER FOR EVAL WAS NOT WARRANTED. THE TREATING PHYSICIAN HAD ALREADY IDENTIFIED BULK HEATING AND TREATMENT TECHNIQUE AS LIKELY CONTRIBUTING FACTORS ALTHOUGH SHE COULD NOT RULE OUT THE USE OF EPINEPHRINE IN THE NERVE BLOCK PRIOR TO THE LASER TREATMENT. POTENTIAL SCARRING IS A KNOWN COMPLICATION AND DESCRIBED IN THE FRAXEL SR LASER SYSTEM LABELING WITH REGARD TO POST-OPERATIVE INFO AND POTENTIAL COMPLICATIONS. TRAINING AND OPERATOR MANUAL FOR THE FRAXEL SR LASER SYSTEM INCLUDED FULL DESCRIPTIONS OF TECHNIQUES TO AVOID BULK HEATING. BASED ON THE REVIEW OF THE MFG RECORDS FOR THE LASER SYSTEM, WE CONCLUDED THE DEVICE PERFORMED AS INTENDED. ALSO THE PHYSICIAN WAS AWARE OF THE TECHNIQUES RELATING TO THIS EVENT, NO CORRECTIVE OR PREVENTIVE ACTION WAS WARRANTED AS TRAINING AND LABELING FOR THE LASER SYSTEM WERE EFFECTIVE. NOTE - AT FIRST REVIEW (ON (B)(6) 2005), THE EVENT WAS THOUGHT TO BE DUE SOLELY TO THE EPINEPHRINE / NERVE BLOCK PROCEDURE USED PRIOR TO THE FRAXEL PROCEDURE. HOWEVER, A SUBSEQUENT REVIEW ((B)(6) 2005) DETERMINED THE INFO WAS SUGGESTING SCARRING DUE TO BULK HEATING AND TREATMENT TECHNIQUE. THE REPORTABILITY OF THE EVENT WAS BASED ON THIS DETERMINATION OF POTENTIAL SCARRING ON (B)(6) 2005.

    Description of Event or Problem · 1

    ON (B)(6) 2005, THE TREATING PHYSICIAN REPORTED THAT 21 DAYS AFTER THE LAST FRAXEL TREATMENT THAT A PT (FEMALE) HAD SCABBING (IN THE AREA OF THE LIP) WHICH HAD "FALLEN OFF TO REVEAL AREAS OF ATROPHY WITH A RAISED EDGE." THE PHYSICIAN'S REVIEW OF THE CASE IDENTIFIED POSSIBLE BULK HEARING AND TREATMENT TECHNIQUE AS CONTRIBUTING FACTORS. ALSO, THE PHYSICIAN ALSO STATED THAT USE OF EPINEPHRINE IN THE NERVE BLOCK MIGHT HAVE CONTRIBUTED TO THIS EVENT. THE PHYSICIAN DESCRIBED THE SYMMETRICAL DISTRIBUTION OF THE LESIONS, OVAL IN SHAPE WHICH DID NOT CONFORM TO THE SHAPE OF THE FRAXEL LASER HAND PIECE. LESION DEPTH AND LOCATION WERE IN AREAS OF RELATIVELY LOWER ENERGY DELIVERY. F/U INFO WAS PROVIDED BY THE TREATING PHYSICIAN ON (B)(6) 2005 AFTER A RECENT VISIT BY THE PT. ALTHOUGH THE EVENT WAS NOT CONSIDERED SERIOUS (NOT LIFE-THREATENING OR CONTRIBUTING TO PERMANENT IMPAIRMENT OR DAMAGE), THE PT'S CURRENT CLINICAL STATUS WAS DESCRIBED AS HAVING AREAS OF SUBTLE SCARRING (ATROPHIC AND HYPERTROPHIC). NECESSARY INTERVENTIONS AND/OR CONCOMITANT THERAPY INCLUDED COSMODERM (COLLAGEN REPLACEMENT THERAPY), PULSE DYE LASER AND SCULPTRA (INJECTABLE SYNTHETIC FILLER).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention