P-SERIES P-440 303070

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-02-20 for P-SERIES P-440 303070 manufactured by Handicare Usa.

MAUDE Entry Details

Report Number3007802293-2020-00004
MDR Report Key9734642
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-02-20
Date of Report2020-02-05
Date of Event2020-01-29
Date Mfgr Received2020-02-04
Date Added to Maude2020-02-20
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 ContactMR LAREN MCINTOSH
Manufacturer Street10888 METRO COURT
Manufacturer CityMARYLAND HEIGHTS, MO
Manufacturer CountryUS
Manufacturer Phone2199135127
Manufacturer G1HANDICARE USA
Manufacturer Street10888 METRO COURT
Manufacturer CityMARYLAND HEIGHTS, MO
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameP-SERIES
Generic NamePATIENT LIFT
Product CodeFSA
Date Received2020-02-20
Model NumberP-440
Catalog Number303070
Device Availability*
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerHANDICARE USA
Manufacturer Address10888 METRO COURT MARYLAND HEIGHTS, MO US


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-20

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