MAXI 500 KM560181

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-16 for MAXI 500 KM560181 manufactured by Arjohuntleigh Magog Inc..

MAUDE Entry Details

Report Number9681684-2020-00020
MDR Report Key9835255
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-02-20
Date Mfgr Received2020-02-20
Device Manufacturer Date2016-12-21
Date Added to Maude2020-03-16
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 ContactKINGA STOLINSKA
Manufacturer StreetKS. WAWRZYNIAKA 2
Manufacturer CityKOMORNIKI 62-052
Manufacturer CountryPL
Manufacturer Postal62-052
Manufacturer Phone688282467
Manufacturer G1ARJOHUNTLEIGH MAGOG INC.
Manufacturer Street2001 TANGUAY STREET
Manufacturer CityMAGOG, QUEBEC J1X 5Y5
Manufacturer CountryCA
Manufacturer Postal CodeJ1X 5Y5
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMAXI 500
Generic NameLIFT, PATIENT, NON-AC-POWERED
Product CodeFSA
Date Received2020-03-16
Model NumberKM560181
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerARJOHUNTLEIGH MAGOG INC.
Manufacturer Address2001 TANGUAY STREET MAGOG, QUEBEC J1X 5Y5 CA J1X 5Y5


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-16

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