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

Model Number NA:MYON

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

Patient Problems Death (1802); Bone Fracture(s) (1870)

Event Date 08/03/2018

Event Type  Death  

Manufacturer Narrative

Invacare was made aware of this event which occurred in the united kingdom involving an rea azalea 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 u.S.Has been determined to be similar in design to the action 3.

Event Description

The patient was being transported in a rea azalea wheelchair, on a community transport bus.She slid forward out of the wheelchair, breaking both legs.She was not wearing the fitted lap belt.Complications during hospital stay leading to death.

• Brand Name: MYON SWINGAWAY WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX MANUFACTURING; 102 parque industrial manimex; reynosa 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 44035 ; 8003336900
• MDR Report Key: 9494571
• MDR Text Key: 171967116
• Report Number: 9616091-2019-00032
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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
• Date Manufacturer Received: 11/22/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other