BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VECTUS

    MDR report key: 3951850 · Received July 2, 2014

    Report

    Report Number
    1222993-2014-00021
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 29, 2014
    Report Date
    July 1, 2014
    Product Code
    GEX
    PMA / PMN Number
    K120622
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CYNOSURE TECHNICIAN INSPECTED HANDPIECE AND IT IS FUNCTIONING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    PATIENT RECEIVED HAIR REMOVAL TREATMENT ON HER FACE AND PRESENTED WITH BURNS. THE PHYSICIAN PRESCRIBED ORAL STEROIDS AS A PROPHYLACTIC PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386214 VECTUS VECTUS GEX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other