BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RETCAM II

    MDR report key: 1244551 · Received November 24, 2008

    Report

    Report Number
    2952489-2008-00001
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 21, 2008
    Manufacturer
    CLARITY MEDICAL SYSTEMS, INC
    Product Code
    HKI
    PMA / PMN Number
    K001275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF THE INVESTIGATION, CLARITY REQUESTED AND OBTAINED ADDITIONAL INFORMATION FROM THE HOSPITAL. THE INFORMATION SUPPLIED BY THE HOSPITAL SHOWS THAT THE INFECTION OCCURRED 5 DAYS AFTER, THE RETCAM DEVICE WAS USED. PATIENT WAS PRESCRIBED SODIUM SULFACETAMIDE AND DISCHARGED. AS THE INJURY OCCURRED SEVERAL DAYS POST EXPOSURE TO OUR PRODUCT, WE DO NOT BELIEVE THAT OUR DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INJURY. ALTHOUGH, THE INITIAL INFORMATION SUPPLIED REPORTED THREE PATIENTS INVOLVED, SUBSEQUENT INFORMATION SHOWS THAT THERE WERE ONLY TWO. BECAUSE OF THE FRAGILE NATURE OF THE PATIENT (NEW-BORN LOW BIRTH WEIGHT INFANT), WE CONSIDER THE EVENT A SERIOUS INJURY AND REPORTABLE.

    Description of Event or Problem · 1

    ON OCTOBER 20, 2008, NURSE REPORTED THAT 3 PATIENTS (IN THE NICU) HAD EYE INFECTIONS ON THE SAME DAY. SHE HAD QUESTIONS ABOUT THE RETCAM'S INFORMATION ON CLEANING. THEY WERE LOOKING AT ALL POSSIBILITIES.

    Description of Event or Problem · 2

    ON OCTOBER 20, 2008, NURSE REPORTED THAT 3 PATIENTS (IN THE NICU) HAD EYE INFECTIONS ON THE SAME DAY. SHE HAD QUESTIONS ABOUT THE RETCAM'S INFORMATION ON CLEANING. THEY WERE LOOKING AT ALL POSSIBILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETCAM II OPHTHALMIC CAMERA HKI CLARITY MEDICAL SYSTEMS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Required Intervention
    2 15 DA Required Intervention