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 2020-02-17 for SITTER ELITE 8345 manufactured by Posey Products, Llc.

MAUDE Entry Details

Report Number2020362-2020-00023
MDR Report Key9717697
Report SourceUSER FACILITY
Date Received2020-02-17
Date of Report2020-02-13
Date Mfgr Received2020-02-13
Device Manufacturer Date2017-07-10
Date Added to Maude2020-02-17
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 ContactCHRIS RAHN
Manufacturer Street570 ENTERPRISE DRIVE
Manufacturer CityNEENAH WI 54956
Manufacturer CountryUS
Manufacturer Postal54956
Manufacturer Phone9207514300
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 Received2020-02-17
Returned To Mfg2020-02-10
Model Number8345
Catalog Number8345
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPOSEY PRODUCTS, LLC
Manufacturer Address2530 LINSAY PRIVADO DRIVE ONTARIO 91761 US 91761


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-17

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