BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL RETINAL CAMERA CF-1

    MDR report key: 2945771 · Received January 28, 2013

    Report

    Report Number
    1000181430-2013-00015
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    February 16, 2011
    Manufacturer
    CANON, INC.
    Product Code
    HKI
    PMA / PMN Number
    K063717
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED RETROACTIVELY AS A RESULT OF AN INTERNAL AUDIT OF COMPLAINT FILES CONDUCTED BY CANON HEALTHCARE SOLUTIONS USA. THE SERVICE REP CHECKED AND ADJUSTED THE QUICK RETURN MIRROR. THE SYSTEM WAS TESTED FOR SEVERAL DAYS AND NO PROBLEMS WERE OBSERVED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE INTERMITTENT BLACK IMAGES DURING FLUORESCEIN ANGIOGRAPHY. THE CUSTOMER DID NOT MENTION THAT THEY HAD TO RE-INJECT THE PT WITH FLUORESCEIN OR RESCHEDULE THE PT EXAM. HOWEVER, THE INFO SUGGESTS THAT A REPEAT INJECTION MAY HAVE BEEN NECESSARY DURING THE EXAM OR A RESCHEDULED EXAM DUE TO THE BLACK IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38018 DIGITAL RETINAL CAMERA CF-1 HKI CANON, INC. CF-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other