NON-LOCKING TWICE-AS-TOUGH CUFFS 2790

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 2019-11-27 for NON-LOCKING TWICE-AS-TOUGH CUFFS 2790 manufactured by Posey Products Llc.

MAUDE Entry Details

Report Number2020362-2019-00216
MDR Report Key9387385
Report SourceUSER FACILITY
Date Received2019-11-27
Date of Report2019-11-01
Date Mfgr Received2019-11-01
Date Added to Maude2019-11-27
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 Phone6264433143
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNON-LOCKING TWICE-AS-TOUGH CUFFS
Generic NameRESTRAINT, PROTECTIVE
Product CodeFMQ
Date Received2019-11-27
Model Number2790
Catalog Number2790
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerPOSEY PRODUCTS LLC
Manufacturer Address570 ENTERPRISE DRIVE NEENAH WI 54956 US 54956


Patients

Patient NumberTreatmentOutcomeDate
10 2019-11-27

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