PENTAX OE-A63

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-04 for PENTAX OE-A63 manufactured by Hoya Corporation Pentax Tokyo Office.

MAUDE Entry Details

Report Number9610877-2020-00048
MDR Report Key9788361
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-04
Date of Report2020-02-04
Date of Event2020-01-10
Date Mfgr Received2020-02-04
Date Added to Maude2020-03-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPHYSICIAN ASSISTANT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. WILLIAM (TEMPORARY)
Manufacturer Street3 PARAGON DRIVE
Manufacturer CityMONTVALE, NJ
Manufacturer CountryUS
Manufacturer Phone4315880231
Manufacturer G1HOYA CORPORATION PENTAX TOKYO OFFICE
Manufacturer StreetTSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI
Manufacturer CityTOKYO, 196-0012
Manufacturer CountryJA
Manufacturer Postal Code196-0012
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePENTAX
Generic NameSINGLE USE DISTAL END CAP WITH ELEVATOR
Product CodeFDT
Date Received2020-03-04
Model NumberOE-A63
Lot Number0011019
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerHOYA CORPORATION PENTAX TOKYO OFFICE
Manufacturer AddressTSUTSUJIGAOKA 1-1-110 AKISHIMA-SHI TOKYO, 196-0012 JA 196-0012


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-04

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