BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HGM ARGON LASER

    MDR report key: 18607 · Received August 2, 1994

    Report

    Report Number
    18607
    Event Type
    Injury
    Date Received
    August 2, 1994
    Date of Event
    February 7, 1994
    Report Date
    February 7, 1994
    Manufacturer
    HGM, INC.
    Product Code
    HQF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ARGON LASER WAS SET UP ACCORDING TO PROCEDURE. PHYSICIAN ASKED TO REDUCE POWER SETTING BUT IT DID NOT DECREASE. PHYSICIAN STATED THAT POWER OF LASER BEAM CAUSED A HOLE IN PATIENTS RETINA. BIOMED INSPECTION OF THE LASER INDICATED LASER POWER OUTPUT TO BE WITHIN SPECS. TRYING TO OBTAIN AN INDEPENDENT REVIEW OF LASER ON SITE. CURRENTLY IT IS IMPOUNDED BY RISK MGT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HGM ARGON LASER EYE LASER HQF HGM, INC. 5 ARGON

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| S