NSK Z95L C1034001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-23 for NSK Z95L C1034001 manufactured by Nakanishi Inc..

MAUDE Entry Details

Report Number1422375-2020-00003
MDR Report Key9866581
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-02-04
Date Facility Aware2020-02-04
Report Date2020-03-23
Date Reported to FDA2020-03-23
Date Reported to Mfgr2020-03-23
Date Added to Maude2020-03-23
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
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
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNSK
Generic NameDENJTAL HANDPIECE
Product CodeEGS
Date Received2020-03-23
Returned To Mfg2020-03-18
Model NumberZ95L
Catalog NumberC1034001
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age5 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNAKANISHI INC.
Manufacturer Address700 SHIMOHINATA KANUMA-SHI, TOCHIGI-KEN 322-8666 JA 322-8666


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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