BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNAMIC COLLING DEVICE

    MDR report key: 399360 · Received June 12, 2002

    Report

    Report Number
    1218402-2002-00020
    Event Type
    Injury
    Date Received
    June 12, 2002
    Report Date
    June 6, 2002
    Manufacturer
    CANDELA CORP.
    Product Code
    GEH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR REPORTED BLISTERING AND SCARRING SEVERAL PTS AFTER A LASER DERMATOLOGY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DYNAMIC COLLING DEVICE DERMATOLOGY CRYOGEN DELIVERY SYSTEM GEH CANDELA CORP. 9904-00-0100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other