BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICOWAY

    MDR report key: 8445646 · Received March 22, 2019

    Report

    Report Number
    1218402-2019-00005
    Event Type
    Injury
    Date Received
    March 22, 2019
    Date of Event
    January 29, 2019
    Report Date
    May 17, 2019
    Manufacturer
    CANDELA CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K170597
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ON 03/27/2019, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE LASER AND FOUND THAT THE LENS WAS BURNT ON THE ZOOM HANDPIECE; THE 1064 RESOLVE HANDPIECE WAS CLOUDY. OTHER OPERATIONS OF THE UNIT WERE OKAY; NO ISSUES. THE PICOWAY LASER SYSTEM OPERATOR'S MANUAL WARNS THAT EXCESSIVE PERSPIRATION TO THE TREATED AREA MAY CAUSE TISSUE DISRUPTION. PHYSICAL EXERCISE SHOULD BE DISCONTINUED FOR 1 TO 2 DAYS TO REDUCE THE RISK OF INFECTION. DURING A FOLLOW-UP CALL WITH NURSE, THE PATIENT REPORTED THAT SHE COVERED THE AREA WITH SARAN WRAP. SARAN WRAP IS NOT A BREATHABLE MATERIAL WHICH MAY HAVE CAUSED SWEATING WHICH IS A RISK FACTOR FOR INFECTION AFTER TREATMENT, IN THIS CASE, CELLULITIS. THEREFORE, THE CAUSE FOR THIS EVENT IS KNOWN INHERENT RISK OF DEVICE INDICATING THAT THE REPORTED ADVERSE EVENT IS KNOWN AND DOCUMENTED IN THE LABELING, INCLUDING BOTH SHORT OR LONG TERM KNOWN COMPLICATIONS OR ADVERSE REACTIONS.

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED TECHNICAL SUPPORT TO REPORT THAT A FEMALE PATIENT (SKIN TYPE 3) EXPERIENCED AN ADVERSE REACTION REQUIRING MEDICAL INTERVENTION THREE (3) DAYS POST TATTOO-REMOVAL TREATMENT ON HER UPPER LEFT ARM. AFTER PERFORMING A TEST SPOT, PATIENT WAS TREATED ON (B)(6) 2019 USING THE SAME SETTINGS USED FOR 2 PREVIOUS TATTOO-REMOVAL TREATMENTS; BOTH OF THOSE TREATMENTS WERE WITHOUT ISSUE. RECENT SUN EXPOSURE WAS REPORTED; PATIENT HAD BEEN IN THE (B)(6) OVER THE HOLIDAYS, BUT DENIED TAN. POST TREATMENT, THERE WAS FROSTING PRESENT AND NO PINPOINT BLEEDING; AREA APPEARED AS EXPECTED FOLLOWING TREATMENT. DURING A FOLLOW-UP CALL WITH NURSE, PATIENT REPORTED THAT SHE COVERED THE AREA WITH SARAN WRAP AND WAS TOLD TO REMOVE IT AND NOT USE FOLLOWING TREATMENTS. PATIENT RETURNED TO SKIN DEEP LASER SPA 3 DAYS LATER WITH MAJOR SWELLING IN THE UPPER LEFT ARM; WAS DIAGNOSED WITH CELLULITIS AND SENT TO EMERGENCY ROOM, AND ADMITTED FOR TREATMENT. PER NURSE'S REPORT, INJURY IS EXPECTED TO HEAL. MULTIPLE FOLLOW-UP ATTEMPTS HAVE BEEN MADE WITH CLINIC TO OBTAIN HOSPITAL DISCHARGE INFORMATION. TO DATE, NO FURTHER INFORMATION HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237733 PICOWAY PICOWAY GEX CANDELA CORPORATION 9914-00-9060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization