INNOWAVE PCF SONIC IRRIGATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-12 for INNOWAVE PCF SONIC IRRIGATOR manufactured by Medisafe Uk Ltd..

MAUDE Entry Details

Report Number9617134-2019-00001
MDR Report Key8693163
Date Received2019-06-12
Date of Report2019-06-12
Date of Event2019-05-13
Date Mfgr Received2019-05-13
Date Added to Maude2019-06-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. DANIEL DAVY
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927453
Manufacturer G1MEDISAFE UK LTD.
Manufacturer StreetTWYFORD RD./THE SNAP FACTORY BISHOP STORTFORD
Manufacturer CityHERTFORSHIRE HERTFORDS, CM233LJ
Manufacturer CountryUK
Manufacturer Postal CodeCM23 3LJ
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameINNOWAVE PCF SONIC IRRIGATOR
Generic NameSONIC IRRIGATOR
Product CodeFLG
Date Received2019-06-12
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMEDISAFE UK LTD.
Manufacturer AddressTWYFORD RD./THE SNAP FACTORY BISHOP STORTFORD HERTFORSHIRE HERTFORDS, CM233LJ UK CM23 3LJ


Patients

Patient NumberTreatmentOutcomeDate
10 2019-06-12

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