ALARM SENSOR, BED SENSOR PAD 6MTH 8307

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-08-22 for ALARM SENSOR, BED SENSOR PAD 6MTH 8307 manufactured by Posey Products,llc.

MAUDE Entry Details

Report Number2020362-2019-00174
MDR Report Key8923919
Report SourceDISTRIBUTOR,FOREIGN
Date Received2019-08-22
Date of Report2019-07-26
Date Mfgr Received2019-07-26
Device Manufacturer Date2018-11-06
Date Added to Maude2019-08-22
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 NameALARM SENSOR, BED SENSOR PAD 6MTH
Generic NameMONITOR, BED PATIENT
Product CodeKMI
Date Received2019-08-22
Model Number8307
Catalog Number8307
Lot Number8309T031
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerPOSEY PRODUCTS,LLC
Manufacturer Address5635 PECK ROAD ARCADIA CA 91006 US 91006


Patients

Patient NumberTreatmentOutcomeDate
10 2019-08-22

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