BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL RETINAL CAMERA CX-1

    MDR report key: 2945792 · Received January 28, 2013

    Report

    Report Number
    1000181430-2013-00025
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    August 1, 2011
    Manufacturer
    CANON, INC.
    Product Code
    NFJ
    PMA / PMN Number
    K092565
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 DEALER SVC REP REPLACED THE EXPOSURE SWITCH UNIT. THE SYSTEM IS WORKING FINE NOW. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS A SHADOW ON THE LEFT SIDE OF THE IMAGE. THE PROBLEM APPEARS INTERMITTENTLY IN FLUORESCEIN IMAGING MODE ONLY. 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 SHADOW ON THE IMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37841 DIGITAL RETINAL CAMERA CX-1 NFJ CANON, INC. CX-1 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other