ENCORE SYSTEM FG0002

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-06-28 for ENCORE SYSTEM FG0002 manufactured by Siesta Medical Inc..

MAUDE Entry Details

Report Number3008792120-2019-00001
MDR Report Key8745749
Report SourceHEALTH PROFESSIONAL
Date Received2019-06-28
Date of Report2019-06-17
Date of Event2019-05-29
Date Mfgr Received2019-05-29
Date Added to Maude2019-06-28
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 ContactMR. TEDD HINTON
Manufacturer Street101 CHURCH STREET SUITE 3
Manufacturer CityLOS GATOS CA 95030
Manufacturer CountryUS
Manufacturer Postal95030
Manufacturer Phone4085963148
Manufacturer G1SIESTA MEDICAL INC.
Manufacturer Street101 CHURCH STREET SUITE 3
Manufacturer CityLOS GATOS CA 95030
Manufacturer CountryUS
Manufacturer Postal Code95030
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENCORE SYSTEM
Generic NameTONGUE/HYOID SUSPENSION
Product CodeORY
Date Received2019-06-28
Model NumberFG0002
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSIESTA MEDICAL INC.
Manufacturer Address101 CHURCH STREET SUITE 3 LOS GATOS CA 95030 US 95030


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-06-28

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