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

Model Number NA:MYON

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fall (1848)

Event Date 12/30/2021

Event Type  Death  

Event Description

This event took place in (b)(6).The dealer reported that the patient allegedly fell from the action4 wheelchair, and was found on the floor by her caregiver.She passed away the following night.

Manufacturer Narrative

This report is being filed in an abundance of caution.Invacare was made aware of an event in (b)(6) involving an action 4ng wheelchair.Invacare is filing this report because the myon wheelchair, manufactured at invacare owned invamex and sold in the us has been determined to be similar in design to the reported device.The device is being returned to invacare (b)(4) for further evaluation but has not yet been received.It is unknown what if any malfunction occurred, or how, or if, the device contributed to the outcome of the patient, due to the cause of death is not yet known.A follow up will be filed when further information is obtained.

• Brand Name: MYON SWINGAWAY WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria 44036 ; 8003336900
• MDR Report Key: 13385098
• MDR Text Key: 284624787
• Report Number: 9616091-2022-00002
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:MYON
• Device Catalogue Number: MYON
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/30/2021
• 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 Sequence Number: 1
• Patient Outcome(s): Death