FDA.reportPublic FDA data

MAUDE MDR 6716341

MDR report key
6716341
Report number
0002936921-2017-00018
Event key
0
Event type
3
Date of event
2017-06-30
Date received
2017-07-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MRS. PREETI GANDHI BHATIA
Address
47651 WESTINGHOUSE DRIV FREMONT CA 94539 US
Phone
800-800-8002
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RT-5100REFRACTORNIDEK CO., LTD.HKNN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-07-140

Event Narratives#

N

Patient 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 PERFORM THE CORRECTION AS PER Z-1245-2016.

D

Patient 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.