BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANDELA PULSED DYE LASER

    MDR report key: 21281 · Received February 1, 1994

    Report

    Report Number
    21281
    Event Type
    Injury
    Date Received
    February 1, 1994
    Date of Event
    November 17, 1993
    Report Date
    November 30, 1993
    Manufacturer
    CANDELA
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    LASER WAS UTILIZED TO TREAT PORT WINE STAIN ON RIGHT CHEEK. AN ORAL ANESTHESIA MASK, WAS ALSO BEING UTILIZED. AFTER PROVIDING TREATMENT TO THE RIGHT CHEEK AREA, THE NEXT AREA OF TREATMENT WAS TO BE NEAR THE RIGHT SIDE OF THE NOSE. THE ORAL ANESTHESIA MASK WAS REPOSITIONED AND THE PATIENT RECEIVED A SECOND DEGREE BURN 1/8" X 1/4" LONG ALONGSIDE THE LEFT SIDE OF THE FACE.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANDELA PULSED DYE LASER CANDELA SPTL - 1A

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention