RT-5100

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-07-14 for RT-5100 manufactured by Nidek Co., Ltd..

Event Text Entries

[80281664] 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.
Patient Sequence No: 1, Text Type: N, H10


[80281665] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936921-2017-00016
MDR Report Key6716033
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-07-14
Date of Report2017-07-14
Date of Event2017-06-30
Date Mfgr Received2017-06-30
Device Manufacturer Date2011-07-21
Date Added to Maude2017-07-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. PREETI GANDHI BHATIA
Manufacturer Street47651 WESTINGHOUSE DRIVE
Manufacturer CityFREMONT CA 945397474
Manufacturer CountryUS
Manufacturer Postal945397474
Manufacturer Phone8002239044
Manufacturer G1NIDEK CO., LTD.
Manufacturer Street34-14 HIROISHI
Manufacturer City443-0038
Manufacturer CountryJA
Manufacturer Postal Code443-0038
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberZ-1245-2016
Event Type3
Type of Report3

Device Details

Brand NameRT-5100
Generic NameREFRACTOR
Product CodeHKN
Date Received2017-07-14
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerNIDEK CO., LTD.
Manufacturer Address34-14 HIROISHI GAMAGORI, AICHI 443-0038 JA 443-0038


Patients

Patient NumberTreatmentOutcomeDate
10 2017-07-14

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