MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL CAREX; TRIO ROLLER WALKER

Model Number FGA33300 0000

Device Problem Human-Device Interface Problem (2949)

Patient Problem Hip Fracture (2349)

Event Date 01/29/2023

Event Type  Injury  

Event Description

Caller wanted to return the unit because amazon would not take it back.It was purchased for her mother but was not appropriate for her mother's health situation.Her mother was using it around 5:45 am and fell and broke her hip.Caller was adamant about not calling to report any injury or any issues with the unit after 3 weeks her mother fell and broke her hip and is in a rehab facility now.She is not weight bearing on her right hip and she can't use a 3 wheeled walker.Purchased on amazon and they are not allowing return.Daughter states she does not believe the walker caused the fall but her mother's weight bearing status.Said occurred at quarter til 5 and learning to use it and she fell.States she is a nurse and knows there is nothing wrong with it, just her weight bearing status.Warning insert attached.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." 6th bulletin: "always maintain good posture while using the rollator.When walking with the rollator, keep your feet in line with the rear wheels, and do not let the rollator get too far in front of you.".

• Brand Name: CAREX
• Type of Device: TRIO ROLLER WALKER
• Manufacturer (Section D): HEBEI HEALTHPLUS MEDICAL; no. 1, chuangye street, southw; matou ecological industry park; handan city hebei, cn 05604 6; CH 056046
• MDR Report Key: 16466918
• MDR Text Key: 310503016
• Report Number: 3012316249-2023-00002
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/02/2023

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2023
• Distributor Facility Aware Date: 02/10/2023
• Date Report to Manufacturer: 03/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female