BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIXEL CO2

    MDR report key: 5869936 · Received August 11, 2016

    Report

    Report Number
    3004167969-2014-00002
    Event Type
    Injury
    Date Received
    August 11, 2016
    Date of Event
    September 7, 2013
    Report Date
    February 10, 2014
    Manufacturer
    ALMA LASERS LTD
    Product Code
    GEX
    PMA / PMN Number
    K103501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS IS A RESUBMISSION OF 2014 MDR. PLEASE SEE SUBMISSION COMMENT FOR EXPLANATION ON (B)(6)2014 THE CUSTOMER FURTHER REPORTED THAT THEY PERFORMED 25 PROCEDURES BETWEEN THE TIME OF FIRST COMPLAINT AND (B)(6) AND OBSERVED THAT ALL THE PATIENTS SUSTAINED MICRO-PRINT SPOTS. THEY EVEN PERFORMED THE PROCEDURE AT LOW ENERGY THAN WHAT WAS DIRECTED IN THE PROTOCOL. FURTHER TO NOTE WAS THAT THE LOW DOSES DID NOT HAVE PROMISING RESULTS EITHER AND LEFT THE PATIENTS DISSATISFIED. THE CLINICAL TEAM WAS NOT ABLE TO REPRODUCE THE ISSUE WITH A SIMILAR DEVICE AND AS HYPO PIGMENTATION IS A KNOWN SIDE-EFFECT OF THE PROCEDURE SO IT WAS NOT REPORTED AT THAT TIME. THE CLINICAL TEAM WAS NOT ABLE TO REPRODUCE THE ISSUE AND SUGGESTED LOW ENERGIES FOR SKIN TYPE I AND II (LIGHTER SKIN). HOWEVER AT THIS POINT ALMA LTD TEAM DID RE-EVALUATE IF THIS EVENT WAS REPORTABLE AND THUS MISSED THE 30 DAYS DEADLINE. THE SUSPECTED DEVICE WAS REQUESTED BACK TO (B)(4). THE SHIPPING ARRANGEMENTS TOOK A LOT OF TIME AND THE DEVICE WAS RECEIVED BY ALMA LTD ON JUNE 8TH'2014. THE DEVICE PASSED A FULL-FUNCTIONAL TEST. ALL MEASURED PARAMETERS WERE WITHIN THE DEFINED SPECIFICATIONS. THE MEASURED OUTPUT POWER WAS ALSO CLOSE TO THE LOWER EDGE OF DEFINED RANGE. IN THE MEANTIME THE CLINICAL TEAM FOLLOWED-UP ON THE PATIENTS ON (B)(6) 2014. THE CUSTOMER MENTIONED THAT LAST SHE SAW THE PATIENTS WAS IN (B)(6) AND AT THAT TIME THEY DID HAVE VISIBLE MICRO-PRINT SPOTS. THE CUSTOMER ALSO MENTIONED THAT THE PATIENTS WILL COME BACK IN FALL. IT WAS RECOMMENDED TO THE CUSTOMER TO USE COOLING SYSTEM ZIMMER ALMA LTD. CONSIDERS THIS AN INCONCLUSIVE INVESTIGATION. SHOULD ANY ADDITIONAL INFORMATION BE OBTAINED OR RECEIVED, ALMA LTD WILL FILE A SUPPLEMENTAL REPORT(S) WITH FDA WITHIN FDA PUBLISHED TIME-LINES FOR SUCH REPORTING.

    Description of Event or Problem · 1

    ALMA LASERS LTD WAS NOTIFIED OF THIS EVENT ON 02/10/2014. IT WAS REPORTED BY THE CUSTOMER THAT THE PATIENT SUSTAINED VISIBLE MICRO-PRINT WHITE SPOTS (HYPO PIGMENTATION DOTS) ON THE FACE THAT PERSISTED FOR MONTHS AFTER TREATMENT WITH PIXEL CO2 LASER AT MEDIUM AND HIGH MODE SETTINGS. THE LOW MODE SETTINGS DID NOT HAVE THIS POST-TREATMENT COMPLICATION. AT THAT TIME IT WAS NOT CONSIDERED AS AN ADVERSE EVENT AS HYPO-PIGMENTATION IS CONSIDERED A KNOWN SIDE-EFFECT OF THE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521008 PIXEL CO2 MEDICAL LASER GEX ALMA LASERS LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other