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

Model Number NA:MYON

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Fall (1848)

Event Date 09/06/2018

Event Type  Injury  

Manufacturer Narrative

Invacare was made aware of this event which occured in the (b)(6) involving an action3 ng sp wheelchair which was manufactured by invacare (b)(4).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 action3 ng sp.The client stated that when propelling (foot propels using right foot and right hand) through the living room the bolt came out of the top hole on castor assembly and the castor assembly rotated back under the chair causing the client to fall from the chair landing on the side affected by a previous stroke.The client injured their ribs requiring antibiotics and pain medication invacare (b)(4) has requested the action3 ng sp wheelchair be returned but have not received it as of the date of this filing.If more information is received a follow-up will be submitted.

Event Description

The end user stated that when propelling through living room the bolt came out of the top hole of the castor assembly.The castor assembly flipped back under the chair causing the client to fall from the chair injuring his rib.

• Brand Name: MYON SWINGAWAY WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX MANUFACTURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX MANUFATURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 8116654
• MDR Text Key: 128791080
• Report Number: 9616091-2018-00017
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/30/2018

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
• Device Operator: 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
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 11/29/2018
• 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): Required Intervention