MYON SWINGAWAY WHEELCHAIR NA:MYON

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 2019-11-08 for MYON SWINGAWAY WHEELCHAIR NA:MYON manufactured by Invamex Manufacturing.

MAUDE Entry Details

Report Number9616091-2019-00026
MDR Report Key9295928
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-11-08
Date of Report2019-10-14
Date Mfgr Received2019-10-14
Date Added to Maude2019-11-08
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. JASON FIEST
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1INVAMEX MANUFACTURING
Manufacturer Street102 PARQUE INDUSTRIAL MANIMEX
Manufacturer CityREYNOSA, TAMAULIPAS 88780
Manufacturer CountryMX
Manufacturer Postal Code88780
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMYON SWINGAWAY WHEELCHAIR
Generic NameWHEELCHAIR, MECHANICAL
Product CodeIOR
Date Received2019-11-08
Model NumberNA:MYON
Catalog NumberMYON
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINVAMEX MANUFACTURING
Manufacturer Address102 PARQUE INDUSTRIAL MANIMEX REYNOSA, TAMAULIPAS 88780 MX 88780


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-11-08

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