BEUDAMED
    FDA Adverse Event Other Summary report: N

    VERSAPULSE C

    MDR report key: 115358 · Received August 22, 1997

    Report

    Report Number
    2914019-1997-00024
    Event Type
    Other
    Date Received
    August 22, 1997
    Date of Event
    July 18, 1997
    Report Date
    July 23, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DR DOING A PORT WINE STAIN PROCEDURE ON A BABY. THE BABY RECEIVED THREE SMALL BLISTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPULSE C SURGICAL LASER GEX COHERENT MEDICAL LASER GROUP 220V *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other