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 2017-06-02 for RT-5100 manufactured by Nidek Co., Ltd.

Event Text Entries

[76561398] No serious injury occurred, the doctor involved had minor bleeding on the head, and stated that medical treatment was unnecessary. However, nidek inc considers it a reportable event as the device had malfunction and has a potential to cause or contribute to a serious injury if the malfunction were to recur. Nidek hired third party (noritsu) 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.
Patient Sequence No: 1, Text Type: N, H10


[76561399] On may 15, 2017, during a recall process, nidek inc. Recall coordinator received information from a doctor that the near point rod of rt-5100 serial #(b)(4) had hit him in the head on multiple occasions. Furthermore, the doctor stated that the near point rod has caused him to bleed and form a little scar.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0002936921-2017-00005
MDR Report Key6608983
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-06-02
Date of Report2017-06-02
Date of Event2017-05-15
Date Mfgr Received2017-05-15
Device Manufacturer Date2011-11-10
Date Added to Maude2017-06-02
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 BHATIA
Manufacturer Street47651 WESTINGHOUSE DRIVE
Manufacturer CityFREMONT CA 945397474
Manufacturer CountryUS
Manufacturer Postal945397474
Manufacturer Phone5102265750
Manufacturer G1NIDEK CO., LTD.
Manufacturer Street34-14 HIROISHI
Manufacturer CityGAMAGORI, AICHI 443-0038
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 Received2017-06-02
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
101. Other 2017-06-02

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