BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETWO

    MDR report key: 16733131 · Received April 13, 2023

    Report

    Report Number
    3016496662-2023-00001
    Event Type
    Injury
    Date Received
    April 13, 2023
    Report Date
    August 16, 2023
    Manufacturer
    CANDELA CORPORATION
    Product Code
    GEI
    UDI-DI
    00729010995286
    PMA / PMN Number
    K141507
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CANDELA FIELD SERVICE ENGINEER (FSE) EVALUATED AND TESTED THE DEVICE NO DEVICE PROBLEM FOUND. CANDELA CLINICAL TRAINER DISCOVERED THAT THE CUSTOMER WAS USING A DIFFERENT ULTRASOUND GEL THAN RECOMMENDED. THE GEL THE CUSTOMER WAS USING WAS THINNER AND MELTS WITH HEAT WHICH COULD HAVE CONTRIBUTED TO THE INCIDENT. SINCE THE ETWO/EMATRIX SYSTEM USER MANUAL CAUTIONS: ATTEMPTING TO TRIGGER A PULSE WITHOUT COUPLING GEL OR WITH A NON-RECOMMENDED GEL OF IMPROPER ELECTRICAL CONDUCTIVITY, MAY RESULT IN RF CURRENT PASSING ABOVE THE SKIN, CAUSING EXCESS HEAT AND INJURY, THE MOST PROBABLE CAUSE FOR THIS EVENT IS UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT INDICATING THAT THE INTERACTION BETWEEN THE USER AND DEVICE, OR SAMPLE, CAUSED OR CONTRIBUTED TO THE ERROR. THIS INCLUDES UNINTENDED INAPPROPRIATE USE OF THE DEVICE AND INCORRECT SAMPLE PREPARATION. BASED UPON EVALUATION BY THE FSE, THE SYSTEM WOULD NOT HAVE CONTRIBUTED TO THE REPORTED EVENT. INFORMATION PROVIDED BY THE CUSTOMER DETERMINED THAT A NON-RECOMMENDED GEL WAS USED WHICH IS NOT IN ACCORDANCE WITH TREATMENT GUIDELINES. AS A RESULT, THE ADVERSE EVENT WAS CAUSED PARTIALLY OR WHOLLY BY THE USER OF THE DEVICE.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION AND INVESTIGATION PENDING.

    Description of Event or Problem · 0

    A CUSTOMER IN FLORIDA REPORTED A PATIENT INJURY, WHICH THE CUSTOMER ALLEGED OCCURRED WHILE PROVIDING TREATMENT WITH THE ETWO SUBLIME APPLICATOR; ALLEGING THAT THE HANDPIECE ARCED AND CAUSED AN INJURY. THE CUSTOMER REPORTED THAT SHE USED GEL DURING THE PROCEDURE. THE CUSTOMER STATED THAT THE PATIENT JUMPED AFTER THE FIRST PULSE AND DEVELOPED A "COUPLE OF SCRATCHES." THE CUSTOMER STATED THAT SHE THEN TESTED THE PLATE AND FELT IT WAS COLD, SHE PULSED AGAIN AND HEARD A SOUND. THE CUSTOMER STATED THAT THE PATIENT'S SKIN WAS "BURNT BADLY." CUSTOMER REPORTED THAT A CREAM WAS PRESCRIBED TO THE PATIENT. NO PATIENT HISTORY OR TREATMENT PARAMETER DETAILS HAVE BEEN PROVIDED. THE CUSTOMER SHARED A PATIENT PHOTO TAKEN FOUR WEEKS POST TREATMENT. THE IMAGE DEPICTS A FEMALE WITH AN INJURY ON HER RIGHT CHEEK. THE IMAGE WAS REVIEWED BY (B)(6) MEDICAL DIRECTOR AND WAS DETERMINED TO BE A FULL THICKNESS INJURY. (B)(6) POSITION IS TO REPORT AN INJURY INDICATING A THIRD-DEGREE BURN, AFFECTING ALL LAYERS OF THE SKIN WITHIN SUBCUTANEOUS TISSUE, AS SUCH AN INJURY OF THIS NATURE MAY LEAD TO PERMANENT UNDERLYING TISSUE DAMAGE. ADDITIONAL INFORMATION HAS BEEN SOLICITED. A (B)(6) CLINICAL TRAINER WORKING WITH THE CUSTOMER DISCOVERED THAT THE CUSTOMER WAS USING AN ULTRASOUND GEL WHICH IS NOT RECOMMENDED FOR USE WITH THE ETWO DEVICE. ADDITIONAL TRAINING WAS PROVIDED. NO FURTHER INFORMATION HAS BEEN RECEIVED REGARDING THE PATIENT'S TREATMENT OR INJURY TO DATE. THE DEVICE EVALUATION IS PENDING. THIS CASE WILL BE REASSESSED UPON RECEIPT OF NEW AND OR RELEVANT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027358 ETWO ETWO GEI CANDELA CORPORATION 00729010995286

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other