MAUDE Adverse Event Report: INVAMEX 9000 XT SWINGAWAY FRAME STYLE; MANUAL WHEELCHAIR

Model Number NA:9XT

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Muscle/Tendon Damage (4532)

Event Type  Injury  

Manufacturer Narrative

The end user did not have any fractures but does have a torn rotator cuff from the incident.He is receiving physical therapy for the injury.A return was requested but no longer expected due to the wheelchair was stolen from the end user¿s porch.The end user recently got the wheelchair and stated that he only used it for one day.This chair is approximately 12 years old and was a dealer¿s floor sample purchased as is by the end user.It is unknown if the chair had any previous damage prior to being used by the end user.

Event Description

Customer states he was going downhill to his mailbox and the front left caster wheel started to shake.He stated he tried to engage the wheel locks to stop him, but the chair ended up tipping over and he hit the asphalt with the full weight of his body on his shoulder.He states the neighbors helped him get back to the house and he went to have x-rays done of his shoulder.

• Brand Name: 9000 XT SWINGAWAY FRAME STYLE
• Type of Device: MANUAL WHEELCHAIR
• Manufacturer (Section D): INVAMEX; 102 parque industrial manimex; reynosa, tamauilipas 88780 ; MX 88780
• Manufacturer (Section G): INVAMEX; 102 parque industrial manimex; reynosa, tamauilipas 88780 ; MX 88780
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 13153393
• MDR Text Key: 283161369
• Report Number: 9616091-2022-00001
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: NA:9XT
• Device Catalogue Number: 9XT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• 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): Other
• Patient Sex: Male