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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INVAMEX MANUFACTURING MYON SWINGAWAY WHEELCHAIR WHEELCHAIR, MECHANICAL

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INVAMEX MANUFACTURING MYON SWINGAWAY WHEELCHAIR WHEELCHAIR, MECHANICAL Back to Search Results
Model Number NA:MYON
Device Problem Unclear Information (4052)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative

Invacare was made aware of this event in the france involving a acton 2 ng wheelchair which was manufactured by invacare france. Invacare is filing this report because the myon wheelchair, made at invacare owned invamex and sold in the us has been determined to be similar in design to the action 3 sp. The action wheelchair has not been returned to invacare france for an evaluation despite being requested. Further information was received stating the wheelchair was in good condition with no defects. The report from the patient death is being kept confidential. If more information becomes available, a supplemental record will be filed.

 
Event Description

The patient was using an elevator in a hospital with an action 2 ng wheelchair. When going out from the elevator in a backwards position, he took support on the elevator doors using his two hands to push out the wheelchair. While pushing and having both hands at the elevator doors he tilted and fell forward out of the chair. Visually he had no injury and went to his room to sleep. The next day he mentioned a headache, and passed away 3 days later.

 
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Brand NameMYON SWINGAWAY WHEELCHAIR
Type of DeviceWHEELCHAIR, MECHANICAL
Manufacturer (Section D)
INVAMEX MANUFACTURING
102 parque industrial manimex
reynosa, tamaulipas 88780
MX 88780
Manufacturer (Section G)
INVAMEX MANUFACTURING
102 parque industrial manimex
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
jason fiest
one invacare way
elyria, OH 44036
8003336900
MDR Report Key9494607
MDR Text Key171966946
Report Number9616091-2019-00033
Device Sequence Number1
Product Code IOR
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 11/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberNA:MYON
Device Catalogue NumberMYON
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 12/19/2019 Patient Sequence Number: 1
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