BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VBEAM PRIMA

    MDR report key: 11592215 · Received March 30, 2021

    Report

    Report Number
    1218402-2021-00021
    Event Type
    Injury
    Date Received
    March 30, 2021
    Date of Event
    February 5, 2021
    Report Date
    March 11, 2021
    Manufacturer
    CANDELA CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K183452
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IS NOT YET COMPLETED. (B)(4). A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON RECEIPT OF NEW AND/OR RELEVANT INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A (B)(6) CAUCASIAN MALE PATIENT WITH A CAPILLARY VASCULAR FORMATION, PORT WINE STAIN (PWS), INVOLVING HIS RIGHT FOREHEAD AND UPPER EYELID, HAD A HISTORY OF MANY LASER TREATMENTS IN CHILDHOOD AS WELL AS A MORE RECENT TREATMENT WITH ANOTHER LASER ((B)(6) 2019). THE PATIENT HAD PULSED-YELLOW-DYE TREATMENT WITH THE VBEAM PRIMA ON (B)(6) 2021. THE PATIENT WAS TREATED WITH A 10 MILLIMETER SPOT SIZE, A FLUENCE OF 10 JOULES PER CENTIMETER-SQUARED, A PULSE DURATION OF 1.5 MILLISECONDS, AND THE DYNAMIC COOLING DEVICE SET TO "HIGH." METAL EYESHIELDS WERE USED AND THE HANDPIECE WAS INTENTIONALLY DEFOCUSED APPROXIMATELY 0.5 CENTIMETERS OFF THE SKIN FOR THE EYELIDS, BUT PLACED ON THE SKIN ON THE FOREHEAD. CUSTOMER REPORTED THAT THE PATIENT RECEIVED 137 PULSES TO THE TREATED AREA WITH THE EXPECTED PURPURA. PATIENT REPORTED SOME MILD CRUSTING POST TREATMENT. THE PATIENT THEN DEVELOPED HEAVY CRUSTING, SEVERE PAIN, PERIORBITAL CELLULITIS, AND SKIN TEXTURE CHANGES WITH PITTING AND PROLONGED ERYTHEMA. THE CUSTOMER REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM 5 DAYS POST LASER TREATMENT, HAD AN OPHTHALMOLOGY CONSULTATION, AND WAS ADMITTED TO THE HOSPITAL FOR INTRAVENOUS ANTIBIOTIC THERAPY. THE PATIENT HAD ADDITIONAL OPHTHALMOLOGY FOLLOW UP POSTOP DAYS 7 AND 12; AND PLASTIC SURGERY FOLLOW UP ON POSTOP DAY 33. PATIENT TREATED WITH POLYSPORIN OINTMENT, UNTIL HEALED, AND THEN WITH SCAR GEL. CUSTOMER REPORTS THAT THE PATIENT'S CRUSTING HAS HEALED; THE PATIENT COMPLAINS OF "PERSISTENT BLURRED VISION OF THE RIGHT EYE, AND PITTING INDENTATION OF HIS FOREHEAD, AND PERSISTENT ERYTHEMATOUS SPOTS." THE PATIENT'S MOTHER FEELS THE PATIENT'S SKIN IS "DEEPER RED THAN PRIOR TO THE MOST RECENT LASER TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487714 VBEAM PRIMA PULSED DYE LASER GEX CANDELA CORPORATION 9914-00-9080

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Hospitalization| R