MAUDE Adverse Event Report: MAXHEALTH CORPORATION CAREX; TRIO ROLLER WALKER

Model Number FGA33300 0000

Device Problem Inadequate User Interface (2958)

Patient Problem Brain Injury (2219)

Event Date 11/09/2021

Event Type  Injury  

Event Description

My father has been in the hospital in the neuro icu since tuesday (b)(6) 2021 after a bleed in his head.He fell from his trio walker.After months in the neuro icu, surgeries and in an acute rehab facility, my father is finally home.He is 5'6" 170lbs.A family member threw the trio walker in the garbage out of anger.The customer service representative did not create a case and notify regulatory at time of initial report.This device was a replacement from the first complaint on (b)(6) 2021 where the following was reported for the same type of device: "the end user only used a couple of times as it kept throwing them off balance with it wobbling as they used it.The frame does not appear bent.The end user has stopped using it." a serial number was never obtained and the device was not returned.Warning insert attached: caution! read all instructions and warnings prior to assembly and use, instructions for use and warnings, 4th bulletin: do not use this device if you are unable to evenly balance your weight between the two handles.Do not use this device if you have a history of dizziness, balance problems, or a need for a device that can support heavy leaning.Consult a healthcare provider to determine if this device is right for you.8th bulletin: always have all wheels in contact with the floor/ground while using this device.Failure to maintain wheel contact could result in improper balance of the rollator and cause injury or damage.Warning label attached: warning: during use, your weight should be distributed evenly between the handles.Serious injury can result from improper use.Consult your operating brochure and make sure all parts are securely fastened before use.

• Brand Name: CAREX
• Type of Device: TRIO ROLLER WALKER
• Manufacturer (Section D): MAXHEALTH CORPORATION; 14f, no. 99, section 1; xintai 5th road; xizhi district new taipei city, taipei ; TW
• MDR Report Key: 14573639
• MDR Text Key: 293266759
• Report Number: 3012316249-2022-00011
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/02/2022

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: FGA33300 0000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2022
• Distributor Facility Aware Date: 11/15/2021
• Date Report to Manufacturer: 06/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Male
• Patient Weight: 77 KG