BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RT-5100 REFRACTOR

    MDR report key: 3786848 · Received April 11, 2014

    Report

    Report Number
    2936921-2014-00001
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    NIDEK CO.. LTD
    Product Code
    HKN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NIDEK INC WAS UNDER FDA INSPECTION FROM (B)(4) 2014 AND IT'S STILL ONGOING. WE ARE PREPARING A CORRECTION REPORT TO FDA AND HAD A OPPORTUNITY TO DISCUSS ON OUR CORRECTION STRATEGY WITH (B)(4) DISTRICT OFFICE AND (B)(4). DURING A TELECONFERENCE WITH THEM ON (B)(4), NIDEK INC WAS ADVISED BY A DOCTOR IN (B)(4) THAT A COMPLAINT RELATING LACERATION OF THE NOSE WAS A SERIOUS INJURY AS FOLLOWS "I DON'T THINK THE FIRMS' ANALYSIS OR STRATEGY IS APPROPRIATE. I WOULD CONSIDER BY INJURY TO THE FACE THAT CAN CAUSE SCARRING A SERIOUS INJURY AND IT IS REPORTABLE." WE DETERMINED WE SUBMIT A MDR TO FDA BASED ON THE ADVISE FROM (B)(4). WE SINCERELY APOLOGIZE WE DID NOT SUBMIT THIS MDR WITHIN 30 CALENDER DAYS. ON THE OTHER HAND, OUR CORRECTION STRATEGY IN THE DRAFT OF CUSTOMER NOTIFICATION LATTER WAS ACCEPTED BY ALL FDA ATTENDEES IN THE TELECONFERENCE ON (B)(4). OUR STRATEGY IS TO PROVIDE PREVENTIVE MAINTENANCE KIT INCLUDING HEX WRENCH, GLUE AND INSTRUCTION FOR USE TO ALL CUSTOMERS WHO PURCHASED RT-5100 OR RT-3100.

    Description of Event or Problem · 1

    NIDEK INC RECEIVED A COMPLAINT FROM A CUSTOMER ON (B)(6) 2013 THROUGH U.S. DISTRIBUTOR, (B)(4). RT-5100 NEAR POINT ROD FELL DOWN AND HIT THE DOCTOR'S NOSE WHEN HE USED THE RT-5100 (S/NO. (B)(4)). THE DOCTOR OBTAINED A LACERATION ON HIS NOSE. WE TRIED TO CONTACT THROUGH OUR DISTRIBUTOR AND MEET WITH THE DOCTOR. HOWEVER, OUR VISIT WAS REFUSED BY THE DOCTOR BECAUSE HE THOUGHT IT WAS A NON-SERIOUS INJURY. NIDEK INC AND (B)(4) CONFIRMED THAT HIS INJURY WAS NOT SERIOUS; THEREFORE, THERE WAS NO NEED FOR FURTHER FOLLOW-UP INVESTIGATION TO INJURY LEVEL AS OF (B)(6) 2013. AS NIDEK (B)(4) INVESTIGATED THE DEVICE RETURNED, THEY FOUND THE NEAR POINT ROD HOLDER WAS BENT. IT WAS EVALUATED THAT TOO MUCH PRESSURE WAS APPLIED TO THE HINGE AXIS CONNECTED TO THE NEAR POINT ROD HOLDER. AS THE RESULT, THE SCREW MAY BECOME LOOSEN OR THE HINGE MIGHT BE BROKEN. DURING A TELECONFERENCE WITH FDA (B)(4) DISTRICT OFFICE AND ON (B)(4) 2014, NIDEK INC WAS ADVISED BY A DOCTOR IN (B)(4) THAT A COMPLAINT RELATING LACERATION OF THE NOSE WAS A SERIOUS INJURY AS SHE SAID "I WOULD CONSIDER ANY INJURY TO THE FACE THAT CAN CAUSE SCARRING A SERIOUS INJURY AND IT IS REPORTABLE." WE DETERMINED TO SUBMIT THIS MDR TO (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221731 RT-5100 REFRACTOR NONE HKN NIDEK CO.. LTD RT-5100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention