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

Model Number	NA:MYON
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported when a user was transferring from the action 3ng wheelchair to the toilet, the user had dropped from the wheelchair between the toilet seat and wheelchair.The user could not get up by himself.The door was closed, and the phone was in the kitchen.The user tried to open the door by kicking it but hit his little toe on the wheelchair´s footrest tube.There were no footrests attached.The little toe sustained an open fracture as a result of the impact and was amputated.
Additional Manufacturer Narrative
Invacare was made aware of an event that occurred in finland with an action 3 ng manual wheelchair manufactured by invacare france.This medwatch is being filed in an abundance of caution due to the us manufactured myon wheelchair being similar in design and would likely have the same outcome as this event.The user was attempting to kick open a door, however, the user kicked the footrest tube instead which the user alleged was sharp.This allegation of the footrest tube being sharp has not been confirmed.Invacare france has requested additional information and if the wheelchair was available for evaluation.At this time of filing, no further information has been received.Based on the available information, this event is likely the result of unintended user error and not a malfunction nor defect of the wheelchair.If additional information becomes available, a follow-up medwatch will be filed.

• Brand Name: MYON SWINGAWAY WHEELCHAIR
• Common Device Name: WHEELCHAIR, 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: michael simmons ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 20926467
• Report Number: 9616091-2024-00024
• Device Sequence Number: 5294179
• Product Code: IOR
• UDI-Device Identifier: 00841447102304
• UDI-Public: (01)00841447102304
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: NA:MYON
• Device Catalogue Number: MYON
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown