BEUDAMED
    FDA Adverse Event Summary report: N

    FRAXEL SR750 LASER SYSTEM

    MDR report key: 2623883 · Received March 26, 2007

    Report

    Report Number
    2950711-2007-00004
    Date Received
    March 26, 2007
    Date of Event
    April 21, 2006
    Report Date
    March 6, 2007
    Manufacturer
    RELIANT TECHNOLOGIES, INC.
    Product Code
    GEX
    PMA / PMN Number
    K053047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MFG RECORDS FOR THE SYS REVEALED NO DEVICE NON-CONFORMANCE. IN ADDITION, THE TREATMENT TIP WAS RETURNED FOR INSP WITH NO DEFECT FOUND. ALL RECORDS WERE FOUND TO BE APPROPRIATE AND PER RELIANT SPEC.

    Description of Event or Problem · 1

    ON (B)(6) 2006, A PT (FEMALE, (B)(6) OLD) WAS REPORTED TO HAVE DEVELOPED A BILATERAL ULCERACTION IN THE AXILLA REGION, SUBSEQUENTLY RESULTING IN SCARRING, AFTER RECEIVING A SINGLE TREATMENT WITH THE FRAXEL SR750 LASER SYS. THE TREATMENT WAS PERFORMED AT A SETTING OF 8 MJ/PULSE, 250 MTZ/CM2/PASS, FOR A TOTAL TREATMENT DENSITY OF 2000 MTZ/CM2. THREE WEEKS FOLLOWING TREATMENT ((B)(6) 2006), THE PHYSICIAN INJECTED KENALOG (10 MG/CC) AND PROVIDED THE PT WITH TOPICAL OINTMENT (BACTROBAN) AND TOPICAL DIPROSONE. KENALOG INJECTIONS WERE PERFORMED AGAIN 4 AND 5 MONTHS POST-TREATMENT ((B)(6) 2006). IN ADDITION, A SERIES OF ADD'L FRAXEL LASER TREATMENTS WERE ADMINISTERED BETWEEN (B)(6) 2006 AND (B)(6) 2007. THE TREATING PHYSICIAN CLASSIFIED THE RESPONSE AS A PERMANENT SCAR ON (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FRAXEL SR750 LASER SYSTEM NA GEX RELIANT TECHNOLOGIES, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention BACTROBAN| KENALOG INJECTION: DATE OF TX (B)(6) 2006| DATE OF TX: (B)(6) 2006 -(B)(6) 2007| TOPICAL DIPROSONE| MONTHLY FRAXEL SR750 TREATMENTS (6 ADD'L)