BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMATRIX

    MDR report key: 16440052 · Received February 24, 2023

    Report

    Report Number
    3003772750-2023-00001
    Event Type
    Injury
    Date Received
    February 24, 2023
    Date of Event
    July 14, 2020
    Report Date
    February 24, 2023
    Manufacturer
    CANDELA CORPORATION
    Product Code
    GEX
    PMA / PMN Number
    K101321
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED EVENT OCCURRED IN 2020. A REVIEW OF THE SERVICE HISTORY FOR EMATRIX:(B)(4) REVEALS NO SIMILAR EVENTS ON OR BEFORE (B)(6), 2020. INFORMATION ON SYSTEM SETTINGS/TECHNIQUES IS UNAVAILABLE. AS A RESULT, IT IS UNDETERMINABLE IF THE CUSTOMER USED THE CORRECT SYSTEM SETTINGS/TECHNIQUE AS DESCRIBED IN THE TREATMENT GUIDELINES FOR THE DEVICE IN USE. THEREFORE, THE INVESTIGATION FINDINGS DO NOT LEAD TO A CLEAR CONCLUSION ABOUT THE CAUSE OF THE REPORTED EVENT; CAUSE NOT ESTABLISHED. REVIEW OF RISK MANAGEMENT DOCUMENTS DEMONSTRATE THAT THE REPORTED RISK IS CAPTURED AND ASSESSED. NO FURTHER CORRECTIVE ACTIONS REQUIRED FOR THIS COMPLAINT AT THIS TIME. RISK INFORMATION IS THEN SUBJECT TO PERIODIC RISK REVIEWS AND TREND TRACKING, WHICH MAY REQUIRE ADDITIONAL ACTIONS AND/OR REVIEW.

    Description of Event or Problem · 0

    AN ADVOCATE FOR A PATIENT REPORTED AN ADVERSE EVENT ON (B)(6), 2023, TO CANDELA LEGAL DEPARTMENT, ALLEGING THAT THE PATIENT WAS TREATED "ON OR ABOUT (B)(6), 2020" AT A CLINIC IN RHODE ISLAND. IT WAS REPORTED THAT THE PATIENT HAD "AN EMATRIX SUBLIME LASER TREATMENT." IT WAS REPORTED THAT THE PATIENT, "SUSTAINED SEVERE BURNS TO HER FACE, RESULTING IN PERMANENT SCARRING AND DISFIGUREMENT" AND ALLEGED THAT PATIENT WAS "PHYSICALLY INJURED, EXPERIENCED CONSCIOUS PAIN AND SUFFERING AND SEVERE PERMANENT SCARRING." NO FURTHER DETAILS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2023112 EMATRIX EMATRIX GEX CANDELA CORPORATION EMATRIX:

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other