BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEARL FRACTIONAL ER:YSGG LASER

    MDR report key: 2467768 · Received February 16, 2012

    Report

    Report Number
    2954354-2012-00006
    Event Type
    Other
    Date Received
    February 16, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 16, 2012
    Product Code
    GEX
    PMA / PMN Number
    K080530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY HAS NOT PROVIDED INFORMATION ABOUT THE DEVICE OR TREATMENT.

    Description of Event or Problem · 1

    HYPERTROPHIC SCAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEARL FRACTIONAL ER:YSGG LASER GEX ER:YSGG LASER GEX NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FACELIFT PROCEDURE.| PEARL FRACTIONAL TREATMENT PERFORMED DURING