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	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Invacare was made aware of an event that occurred in united kingdom with an action 4 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.No malfunction of the wheelchair was alleged, the occurrence was the result of unintended user error.It was reported the patient is non-compliant with wearing her lap belt despite being advised multiple times to wear it.The invacare myon jr wheelchairs user manual recommends wearing the seat positioning strap.The user manual also provides instruction for proper navigation over curbs and states to not attempt to ride over curbs or obstacles.If additional information becomes available, a follow-up medwatch will be filed.
Event or Problem Description
It was reported the patient fell out of the action 4 ng wheelchair on (b)(6)2024 around 2pm.She was out with 2 of her caregivers who were pushing her outside.She was not wearing her lap belt.When they tried to go up on to the pavement, the casters were not high enough and hit the curb.She fell forwards out of the wheelchair and fractured her knee and sustained some superficial injuries to her arms and face.She was taken to the hospital where she was treated.The left leg is now in a cast.The ot reporter advised the patient will need surgery to her knee.

• 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: 20778097
• Report Number: 9616091-2024-00023
• Device Sequence Number: 12012881
• Product Code: IOR
• UDI-Device Identifier: 00841447102304
• UDI-Public: (01)00841447102304
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 11/25/2024

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: Health Professional
• 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: 10/30/2024
• Initial Report FDA Received Date: 11/26/2024
• 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: Female