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

Model Number NA:MYON

Device Problem Use of Device Problem (1670)

Patient Problem Abscess (1690)

Event Type  Injury  

Manufacturer Narrative

Invacare was made aware of an event that took place in the (b)(6) involving an action 3 sp wheelchair.It was manufactured by invacare (b)(4) ; in august of 2020.Invacare is filing this report because the myon wheelchair, made at invacare owned by invamex, and sold in the u.S., has been determined to be similar in design to the reported device.The action 3 sp wheelchair was repaired and sent back to the end-user.A follow-up; will be filed if further information is received.

Event Description

Invacare europe was notified of an event that took place in the (b)(6) involving an action 3ng sp self propelled wheelchair.The castor of the action 3 wheelchair got jammed in a drain when the user came down off a curb forward, resulting in a fall.The patient received a ruptured abscess requiring hospitalization.

• Brand Name: MYON SWINGAWAY WHEELCHAIR
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): INVAMEX MANUFACTURING; 102 parque industrial manimex; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX MANUFACTURING; 102 parque industrial manimex; 102 parque industrial manimex; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria 44035 ; 8003336900
• MDR Report Key: 12127218
• MDR Text Key: 260233801
• Report Number: 9616091-2021-00007
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2021
• 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: 06/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2020
• 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