BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RT-5100

    MDR report key: 6652031 · Received June 19, 2017

    Report

    Report Number
    0002936921-2017-00012
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Date of Event
    May 30, 2017
    Report Date
    June 19, 2017
    Manufacturer
    NIDEK CO., LTD
    Product Code
    HKN
    Removal / Correction Number
    Z-1245-2016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SERIOUS INJURY OCCURRED AND NO KNOWN IMPACT OR CONSEQUENCE TO THE TECHNICIAN 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 HIRED THIRD PARTY (B)(4) TO PERFORM THE CORRECTION AS PER RECALL (Z-1245-2016). AT THIS TIME, DEVICE EVALUATION ANTICIPATED BUT HAS NOT BEGUN. THEREFORE, A FOLLOW-UP WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED.

    Description of Event or Problem · 1

    ON MAY 30, 2017, DURING A RECALL PROCESS, NIDEK INC. RECALL COORDINATOR RECEIVED INFORMATION FROM A CUSTOMER THAT THE NEAR POINT ROD OF RT-5100 SERIAL #(B)(4)HAD HIT HER IN THE HEAD ON MULTIPLE OCCASIONS BUT CLAIMED THAT IT WAS NOT A BIG DEAL, OTHER THAN THE INCONVENIENCE AND STATED THAT SINCE NO SERIOUS INJURIES FROM INCIDENT, MEDICAL TREATMENT/INTERVENTION WAS UNNECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433229 RT-5100 REFRACTOR HKN NIDEK CO., LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR