COREGA ADHESIVE STRIPS

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 2019-06-18 for COREGA ADHESIVE STRIPS manufactured by Kyowa Ltd Izumisano Factory.

MAUDE Entry Details

Report Number3004699328-2019-00009
MDR Report Key8707711
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-06-18
Date of Report2019-06-06
Date Mfgr Received2019-06-06
Date Added to Maude2019-06-18
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 NameCOREGA ADHESIVE STRIPS
Generic NameDENTURE ADHESIVE
Product CodeKOL
Date Received2019-06-18
OperatorLAY USER/PATIENT
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerKYOWA LTD IZUMISANO FACTORY
Manufacturer AddressIZUMISANO-CITY, OSAKA JA


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-06-18

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