DISPOSABLE CHAIR ALARM BELT 8399

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 2020-01-30 for DISPOSABLE CHAIR ALARM BELT 8399 manufactured by .

MAUDE Entry Details

Report Number2020362-2020-00001
MDR Report Key9648243
Report SourceUSER FACILITY
Date Received2020-01-30
Date of Report2020-01-03
Date Mfgr Received2020-01-03
Date Added to Maude2020-01-30
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 NameDISPOSABLE CHAIR ALARM BELT
Generic NameFALL PREVENTION ALARM/SENSOR ATTACHED ONLY
Product CodePJP
Date Received2020-01-30
Model Number8399
Catalog Number8399
Lot Number8150T126
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer AddressUS


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.