JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-06 for JAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED) manufactured by Block Drug Co., Inc..

MAUDE Entry Details

Report Number1020379-2020-00005
MDR Report Key9676473
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-02-06
Date of Report2020-01-21
Date Mfgr Received2020-01-21
Date Added to Maude2020-02-06
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 StreetPO BOX 13398 RESEARCH TRIANGLE PARK,
Manufacturer CityNC 27709
Manufacturer CountryUS
Manufacturer Postal27709
Manufacturer Phone8888255249
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJAPANESE POLIDENT FOR PARTIALS (POLIDENT FOR PARTIALS WITH TAED)
Generic NameDENTURE CLEANSER
Product CodeEFT
Date Received2020-02-06
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBLOCK DRUG CO., INC.
Manufacturer AddressMEMPHIS TN US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2020-02-06

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