BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 411364 · Received August 14, 2002

    Report

    Report Number
    MW1025868
    Event Type
    Injury
    Date Received
    August 14, 2002
    Date of Event
    May 14, 2002
    Report Date
    August 14, 2002
    Manufacturer
    UNK
    Product Code
    HQF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAD THE NEWEST "CK" PROCEDURE DONE ON BOTH EYES TO CORRECT FARSIGHTEDNESS. THE DR PLACED 16 DOTS AROUND EACH EYE WITH THE RADIO WAVE PROBE TO RESHAPE THE EYE. IMMEDIATELY AFTER SURGERY PT SAW MULTIPLE IMAGES. AS THE DAYS/WEEKS WENT BY THIS CONDITION SEEMED TO WORSEN. THE DR SAID PT'S EYEBALLS WERE "WARPED" OUT OF SHAPE. HE WANTED TO WAIT FOR FOUR MOS TO HAVE THE EYES STABILIZE BEFORE GOING BACK AND CORRECTING THE PROBLEM WITH THE PLACEMENT OF ANOTHER SINGLE PROBE IN EACH EYE. THIS RADIO WAVE PROBE IS SUPPOSED TO BRING THE EYE BACK INTO SHAPE. PT IS SCHEDULED FOR AN OFFICE VISIT 8/2002 FOR THE FINAL EVALUATION PRIOR TO SURGERY. PT'S CONCERN IS THE DR DOES NOT KNOW WHAT HE IS DOING AS THIS WAS THE FIRST APPROVAL FOR THIS PROCEDURE IN THE STATE AND PT WAS ONE OF THE FIRST PTS ON THE FIRST DAY FOR THIS PROCEDURE BY THIS DR AND CLINIC. HE NOW IS RELYING ON INPUT FROM PRODUCT MFRS TO TELL HIM TO CORRECT THE PROBLEM THEY CREATED. PT IS NOW CONCERNED THEY MAY ACTUALLY MAKE THE PROBLEM WORSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CK EYE LASER HQF UNK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention