BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUERA

    MDR report key: 9218007 · Received October 22, 2019

    Report

    Report Number
    1720381-2019-00011
    Event Type
    Injury
    Date Received
    October 22, 2019
    Date of Event
    September 28, 2019
    Report Date
    October 22, 2019
    Manufacturer
    BIOS SRL
    Product Code
    PBX
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE REPORTED EVENT BY CONTACTING THE USER FACILITY DIRECTLY. PATIENT TREATMENT SETTINGS, PATIENT INFORMATION WAS PARTLY PROVIDED BY THE USER FACILITY. ACCORDING TO THE INCIDENT FORM, A (B)(6) YEAR OLD FEMALE PATIENT WAS TREATED ON THE ABDOMEN WHEN DURING THE TREATMENT THE PATIENT FELT THAT THE HANDPIECE 'SHOCKED' HER AND IMMEDIATELY A LOCALIZED BLISTER DEVELOPED IN THE TREATMENT AREA. THE PATIENT WAS ADVISED TO KEEP 'LASERCYN' GEL APPLIED OVER THE AFFECTED AREA. ACCORDING TO THE INCIDENT FORM, AS OF (B)(6) 2019 THE AFFECTED AREA HAS HEALED. ACCORDING TO A SERVICE CUSTOMER SUPPORT MANAGER, A LUMENIS CLINICAL SPECIALIST CONTACTED THE FACILITY ON (B)(6) 2019 AND SPOKE TO THE CUSTOMER. THE SERVICE HAS SUSPECTED THAT THIS WAS THE RESULT OF 'USER ERROR' WITH NO ALLEGATION OF SYSTEM PERFORMANCE ISSUES. NO SERVICE WAS REQUIRED ON THE DEVICE. MALFUNCTION IS NOT THE SUSPECTED CAUSE OF THE ADVERSE EVENT. SINCE THE DISCUSSION OF THE PROTOCOL BY THE CLINICAL SPECIALIST WITH THE CUSTOMER ON (B)(6) 2019, LUMENIS HAS NOT RECEIVED ANY NEW REPORT OR COMPLAINT ON THIS SYSTEM.. WHILE THE INFORMATION RECEIVED TO DATE DOES NOT CONFIRM THAT A SERIOUS INJURY OCCURRED, BECAUSE OF THE LACK OF INFORMATION THE COMPANY IS REPORTING THE EVENT IN AN ABUNDANCE OF CAUTION. LUMENIS IS NOT THE MANUFACTURER OF THE NUERA DEVICE WHICH WAS USED DURING THIS PROCEDURE, LUMENIS HAS FORWARDED THE INFORMATION OF THIS EVENT TO THE LEGAL MANUFACTURER, BIOS S.R.L.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT ONE (1) PATIENT SUSTAINED BLISTERS TO CHIN FOLLOWING TREATMENT WITH BIOS NUERA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014965 NUERA FAMILY OF RADIOFREQUENCY SYSTEM (BIOREVITAL RF MED, THERMISMOOTH 250) PBX BIOS SRL NUERA

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other