SITTER ELITE 8345

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-08-01 for SITTER ELITE 8345 manufactured by Posey Products Llc.

MAUDE Entry Details

Report Number2020362-2019-00164
MDR Report Key8850844
Report SourceUSER FACILITY
Date Received2019-08-01
Date of Report2019-08-13
Date Mfgr Received2019-08-05
Device Manufacturer Date2012-09-17
Date Added to Maude2019-08-01
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 ContactWILLIAM HINCY
Manufacturer Street5635 PECK ROAD
Manufacturer CityARCADIA CA 91006
Manufacturer CountryUS
Manufacturer Postal91006
Manufacturer Phone6264433143
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSITTER ELITE
Generic NameFALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED
Product CodePJO
Date Received2019-08-01
Model Number8345
Catalog Number8345
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPOSEY PRODUCTS LLC
Manufacturer Address5635 PECK ROAD ARCADIA CA 91006 US 91006


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-01

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