BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT-5100

    MDR report key: 6716033 · Received July 14, 2017

    Report

    Report Number
    0002936921-2017-00016
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    June 30, 2017
    Report Date
    July 14, 2017
    Manufacturer
    NIDEK CO., LTD.
    Product Code
    HKN
    Removal / Correction Number
    Z-1245-2016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY OCCURRED AND NO KNOWN IMPACT OR CONSEQUENCE TO THE DOCTOR INVOLVED. HOWEVER, NIDEK INCORPORATED CONSIDERS THIS ISSUE A REPORTABLE EVENT AS THE DEVICE HAD MALFUNCTIONED AND HAS A POTENTIAL TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. NIDEK INC. IS AWARE OF THIS ISSUE AND CORRECTIVE ACTION HAS BEEN IMPLEMENTED UNDER RECALL Z-1245-2016. NIDEK HIRED A THIRD PARTY (B)(4) TO PERFORMED THE CORRECTION AS PER Z-1245-2016.

    Description of Event or Problem · 1

    ON (B)(6) 2017, DURING RECALL PROCESS, A NIDEK INCORPORATED RECALL COORDINATOR RECEIVED INFORMATION FROM A CUSTOMER THAT THE NEAR POINT CHART ROD ON THEIR RT-5100 SERIAL #(B)(4) FELL SEVERAL TIMES AND HAD HIT HER AND ANOTHER EMPLOYEE ON THE HEAD ON MULTIPLE OCCASIONS. THE COMPLAINANT CLAIMED THAT NO BRUISE OR NO SERIOUS INJURY OCCURRED, AND THEREBY, MEDICAL TREATMENT/INTERVENTION WAS UNNECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496805 RT-5100 REFRACTOR HKN NIDEK CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR