BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VBEAM II (PERFECTA)

    MDR report key: 8228355 · Received January 8, 2019

    Report

    Report Number
    1218402-2018-00015
    Event Type
    Injury
    Date Received
    January 8, 2019
    Date of Event
    December 13, 2018
    Report Date
    December 18, 2018
    Manufacturer
    CANDELA CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K043251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WILL BE INVESTIGATED. THE VBEAM II OPERATOR'S MANUAL, REFER TO PAGE 59 CONTAINS INSTRUCTIONS ON HOW TO HANDLE SPILLS OR EXPOSURE TO THE LASER DYE SOLUTION. IN CASE OF A SPILL OR EXPOSURE TO THE LASER DYE SOLUTION THE DYE SOLUTION MAY BE HARMFUL BY INHALATION, INGESTION OR SKIN ABSORPTION. HANDLE THE USED MEGADYE CARTRIDGE WITH CARE AT ALL TIMES. SEE THE VBEAM CARTRIDGE ASSEMBLY MSDS CANDELA P/N 7121-90-9940 FOR MORE COMPLETE INFORMATION. THE TOXICITY AND HEALTH HAZARD DATA OF THE DYE SOLUTION HAS NOT BEEN ESTABLISHED. FOLLOWING A SPILL OR EXPOSURE: EVACUATE THE AREA AND CLOSE OFF TO ALL PERSONNEL. IN CASE OF EYE CONTACT, IMMEDIATELY FLUSH EYES WITH WATER FOR AT LEAST 15 MINUTES. IN CASE OF SKIN CONTACT, REMOVE CONTAMINATED CLOTHING IMMEDIATELY AND FLUSH SKIN WITH SOAP AND WATER. IN CASE OF INHALATION, REMOVE TO FRESH AIR. IN CASE OF INGESTION, DRINK 2 TO 4 GLASSES OF WATER, INDUCE VOMITING AND CALL A PHYSICIAN. OBTAIN AN OSHA/MSHA APPROVED RESPIRATOR, RUBBER GLOVES, AND SAFETY GOGGLES. IF THERE IS A SPILL, ABSORB THE SPILLED LIQUID WITH VERMICULITE, DRY SAND OR SIMILAR MATERIAL. OBTAIN A CONTAINER THAT CAN BE SEALED SECURELY. CAREFULLY SWEEP UP MATERIAL INTO CONTAINER AND SEAL. VENTILATE THE AREA AND WASH THE SPILL SITE AFTER MATERIAL PICK UP IS COMPLETE. REFER TO THE MSDS FOR DISPOSAL PROCEDURES.

    Description of Event or Problem · 1

    THE PHYSICIAN ASSISTANT OF THE DERMATOLOGY FACILITY REPORTED FINDING LIQUID ALL OVER THE FLOOR AROUND THE LASER MACHINE. THE PHYSICAL ASSISTANT CALLED PROFESSIONAL EMERGENCY RESPONDERS FOR HAZARDOUS MATERIALS TO CLEAN UP THE SPILL. IT WAS REPORTED THAT 12 (INCLUDING 2 PREGNANT WOMEN) PEOPLE REQUESTED MEDICAL ATTENTION FOR HEADACHE, BLURRED VISION AND NAUSEA. CANDELA FOLLOWED-UP ON DEC 17TH WITH OFFICE MANAGER OF THE DERMATOLOGY FACILITY AND CONFIRMED THAT ALL 12 PEOPLE ARE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18768 VBEAM II (PERFECTA) VBEAM II (PERFECTA) GEX CANDELA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization