POLIDENT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-10-02 for POLIDENT manufactured by .

MAUDE Entry Details

Report Number1020379-2019-00048
MDR Report Key9145119
Report SourceCONSUMER
Date Received2019-10-02
Date of Report2019-09-19
Date Mfgr Received2019-09-19
Date Added to Maude2019-10-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
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 NamePOLIDENT
Generic NameDENTURE CLEANSER
Product CodeEFT
Date Received2019-10-02
Lot NumberUNK
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer AddressBLOCK DRUG CO., INC. MEMPHIS, TN US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-10-02

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