FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN

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 2019-11-25 for FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN manufactured by Procter & Gamble Manufacturing Co..

MAUDE Entry Details

Report Number1530449-2019-00005
MDR Report Key9371049
Report SourceCONSUMER
Date Received2019-11-25
Date of Report2019-10-30
Date Mfgr Received2019-10-30
Date Added to Maude2019-11-25
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 ContactMGR. REGULATORY ORAL CARE
Manufacturer Street8700 MASON-MONTGOMERY RD
Manufacturer CityMASON OH 45040
Manufacturer CountryUS
Manufacturer Postal45040
Manufacturer G1PROCTER & GAMBLE MANUFACTURING CO.
Manufacturer Street6200 BRYAN PARK ROAD
Manufacturer CityBROWN SUMMIT NC 27214
Manufacturer CountryUS
Manufacturer Postal Code27214
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFIXODENT DENTURE ADHESIVE, VERSION UNKNOWN
Generic NameADHESIVE, DENTURE
Product CodeKOO
Date Received2019-11-25
Lot NumberNOT AVAILABLE
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPROCTER & GAMBLE MANUFACTURING CO.
Manufacturer Address6200 BRYAN PARK ROAD BROWN SUMMIT NC 27214 US 27214


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention 2019-11-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.