BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTUS

    MDR report key: 12641850 · Received October 15, 2021

    Report

    Report Number
    1222993-2021-00041
    Event Type
    Malfunction
    Date Received
    October 15, 2021
    Date of Event
    September 17, 2021
    Report Date
    October 15, 2021
    Manufacturer
    CYNOSURE LLC
    Product Code
    GEX
    PMA / PMN Number
    K120622
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BURNS ARE EXPECTED SIDE EFFECTS FROM SUCH TREATMENTS. THE DEVICE HISTORY RECORD CONFIRMS THAT THE PRODUCT PASSED AND MET ALL REQUIREMENTS BEFORE RELEASING. UPON EVALUATION, THE CHILLER WOULD INTERMITTENTLY STOP COOLING. TECHNICIAN REPLACED SYSTEM CHILLER TO RESOLVE THE ISSUE. THIS IS CONSIDERED REPORTABLE SINCE THE DEVICE MALFUNCTIONED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SECOND PATIENT EXPERIENCED BURNS WHILE USING VECTUS. FIRST PATIENT WAS REPORTED IN MDR# 1222993-2021-00040.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535556 VECTUS VECTUS GEX CYNOSURE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1