BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    930

    MDR report key: 70349 · Received February 13, 1997

    Report

    Report Number
    2914019-1997-00003
    Event Type
    Malfunction
    Date Received
    February 13, 1997
    Date of Event
    January 13, 1997
    Report Date
    February 13, 1997
    Manufacturer
    COHERENT MEDICAL LASER GROUP
    Product Code
    HQB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE DELIVERED 2 WATTS OF ENERGY WHILE TREATING A PT. THE INCIDENT OCCURRED WHILE TREATING THE FAR PERIPHERY, SO THE DR DOES NOT FEEL THE PT'S VISION WAS COMPROMISED. HOWEVER, IN ANOTHER SITUATION, THIS COULD BE SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 930 OPHTHALMIC ARGON PHOTOCOAGULATOR HQB COHERENT MEDICAL LASER GROUP * *

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR