BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL RETINAL CAMERA CF-1

    MDR report key: 2945793 · Received January 28, 2013

    Report

    Report Number
    1000181430-2013-00021
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    April 2, 2012
    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
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    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. (B)(4): THE SVC REP EXCHANGED THE CUSTOMER'S EOS 40D CAMERA BACK WITH A REFURBISHED 40D CAMERA BACK. NO SUBSEQUENT INFO WAS PROVIDED.(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE FLUORESCEIN IMAGES WERE TRANSFERRING AS ALL BLACK. THE COLOR AND RED-FREE IMAGES WERE OK. 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 TRANSFERRED IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38129 DIGITAL RETINAL CAMERA CF-1 HKI CANON, INC. CF-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other