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

Model Number NA:MYON

Device Problem Fracture (1260)

Patient Problems Bone Fracture(s) (1870); Head Injury (1879); Hematoma (1884)

Event Type  Injury  

Manufacturer Narrative

Invacare was made aware of this event in (b)(6) involving an action 3ng 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 deemed to be similar in design to the action 3ng.The action wheelchair has not been returned to invacare (b)(4).Invacare was informed the device will be made available for product inspection.If additional information becomes available a supplemental record will be filed.

Event Description

It was reported that due to a structural failure of the chassis on the left front fork, the end user fell out of the chair.The official hospital emergency letter, reported a head injury, a rib fracture, and a hematomas.

• 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 MANUFACTURING; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 9295928
• MDR Text Key: 165592057
• Report Number: 9616091-2019-00026
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• 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: 10/14/2019
• 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): Hospitalization