FDA.reportPublic FDA data

MAUDE MDR 6716346

MDR report key
6716346
Report number
0002936921-2017-00020
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 DRIVE 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-5100S FELL SEVERAL TIMES AND HAD HIT HER AND SEVERAL EMPLOYEES ON THE HEAD ON MULTIPLE OCCASIONS. THE FACILITY HAVE TWO RT-5100 REFRACTORS SERIAL # (B)(4) BUT THE COMPLAINANT CLAIMED THAT SHE DON'T KNOW WHICH DEVICE HIT THE FORMER EMPLOYEE. HOWEVER, THE COMPLAINANT CONFIRMED THAT NO BRUISE OR NO SERIOUS INJURY OCCURRED, AND THEREBY, MEDICAL TREATMENT/ INTERVENTION WAS UNNECESSARY.