NSK Z95L C1034

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for NSK Z95L C1034 manufactured by Nakanishi Inc..

MAUDE Entry Details

Report Number9611253-2020-00013
MDR Report Key9908875
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-04-01
Date of Event2020-02-24
Date Mfgr Received2020-03-04
Device Manufacturer Date2017-05-16
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR KENNETH BLOCK
Manufacturer Street800 E CAMPBELL RD. SUITE 202
Manufacturer CityRICHARDSON, TX
Manufacturer CountryUS
Manufacturer Phone4809554
Manufacturer G1NAKANISHI INC.
Manufacturer Street700 SHIMOHINATA
Manufacturer CityKANUMA-SHI, TOCHIGI-KEN 322-8666
Manufacturer CountryJA
Manufacturer Postal Code322-8666
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNSK
Generic NameHANDPIECE, CONTRA- AND RIGHT-ANGLE ATTACHMENT, DENTAL
Product CodeEGS
Date Received2020-03-31
Returned To Mfg2020-03-25
Model NumberZ95L
Catalog NumberC1034
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNAKANISHI INC.
Manufacturer Address700 SHIMOHINATA KANUMA-SHI, TOCHIGI-KEN 322-8666 JA 322-8666


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-31

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