PENTAX ED-3490TK

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 2020-03-12 for PENTAX ED-3490TK manufactured by Hoya Corporation Pentax Tokyo Office.

MAUDE Entry Details

Report Number9610877-2020-00058
MDR Report Key9823883
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-12
Date of Report2020-03-11
Date Mfgr Received2020-03-11
Date Added to Maude2020-03-12
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 ContactMR. WILLIAM GOELLER (TEMPORARY)
Manufacturer Street3 PARAGON DRIVE
Manufacturer CityMONTVALE, NJ
Manufacturer CountryUS
Manufacturer Phone4315880231
Manufacturer G1HOYA CORPORATION PENTAX TOKYO OFFICE
Manufacturer StreetTSUTSUJIGAOKA 1-1-110
Manufacturer CityAKISHIMA-SHI, 196-0012
Manufacturer CountryJA
Manufacturer Postal Code196-0012
Single Use3
Remedial ActionRC
Previous Use Code3
Removal Correction NumberNOT ISSUED YET
Event Type3
Type of Report3

Device Details

Brand NamePENTAX
Generic NameVIDEO DUODENOSCOPE
Product CodeFDT
Date Received2020-03-12
Returned To Mfg2020-03-09
Model NumberED-3490TK
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHOYA CORPORATION PENTAX TOKYO OFFICE
Manufacturer AddressTSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI, 196-0012 JA 196-0012


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-12

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