PENTAX M70151

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-07-03 for PENTAX M70151 manufactured by Pentax Of America, Inc..

MAUDE Entry Details

Report Number2518897-2019-00014
MDR Report Key8760721
Report SourceHEALTH PROFESSIONAL
Date Received2019-07-03
Date of Report2019-06-09
Date of Event2019-05-08
Date Mfgr Received2019-06-09
Date Added to Maude2019-07-03
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 (TEMPORARY)
Manufacturer Street3 PARAGON DRIVE
Manufacturer CityMONTVALE NJ 07645
Manufacturer CountryUS
Manufacturer Postal07645
Manufacturer Phone8004315880
Manufacturer G1PENTAX OF AMERICA, INC.
Manufacturer Street3 PARAGON DRIVE
Manufacturer CityMONTVALE NJ 07645
Manufacturer CountryUS
Manufacturer Postal Code07645
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePENTAX
Generic NameENDOPROIQ SOFTWARE
Product CodeOUG
Date Received2019-07-03
Model NumberM70151
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPENTAX OF AMERICA, INC.
Manufacturer Address3 PARAGON DRIVE MONTVALE NJ 07645 US 07645


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-03

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