MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL ROSCOE; E-SERIES ROLLATOR

Model Number 30164

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Head Injury (1879); Pain (1994); Loss of Vision (2139); Neck Pain (2433); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/27/2022

Event Type  Injury  

Event Description

Transport chair that is prone to suddenly and unexpectedly tipping forward, ejecting its passenger to the ground.In this particular case, an elderly woman, (b)(6), was severely injured as a result of the unreasonably unsafe product.The rollator, however, is unsafe as a transport chair.By its design, the rollator is unstable and is prone to flipping forward when used as a transport chair, thereby ejecting the passenger onto the ground.The rollator defendants failed to provide efficient warnings against using the rollator as a transport chair.The walkway contained a divot, pothole, unsafe lip, or crater that created a hazardous condition and trip hazard, and is below community safety standards.On or around (b)(6), 2022 plaintiff was on the sidewalk at (b)(6) while using the rollator, was being pushed by her son.The wheels caught on the hazardous condition in the flooring and caused plaintiff to tip and fall from rollator.The rollator tipping and ejecting plaintiff caused severe damage to plaintiff, including, but no limited to head injury, neck injury, back injury, loss of vision, other medical injuries and pain and suffering.This caused extreme shock and trauma to plaintiff's fragile body.Economy rollator hang tag attached.Rollator- sitting on your rollator: 1.Make sure your rollator is on a level surface.2.Lock hand brakes of rollator by pressing down on grips toward the ground until they lock into position.3.Turn around until your back is to the rollator.4.Slowly step back until the back of your legs touch the rollator seat.5.When sitting down on the rollator, do not lean to one side or the other.Be sure to distribute your weight evenly at all times.Walking with your rollator: 1.Standing behind the rollator, roll the rollator slowly forward so that rear wheels are a few inches in front of your feet.2.Step forward and place your foot in line with rear wheels but slightly inside of them.3.Maintaining a steady roll forward, place your other foot in line with rear wheels.4.Determine a safe place to keep your feet in line with rear wheels.Do not go on steep slopes or ramps that might cause you to lose control.5.Utilize brakes as needed.Safety precations: do not attempt to adjust or operate rollator without reading all instructions carefully.If there are any problems with your rollator, do not attempt to repair it yourself.Contact the dealer/store that you purchased the rollator from for any needed parts or repair.This product should not be used without proper instruction from a healthcare professional.Roscoe medical assumes no responsibility for any damage or injury caused by improper installation, assembly or use of this product.Do not use your rollator as a wheelchair.Do not use on rough or uneven surfaces.Doing so may cause it to tip-over, resulting in injury.Never use stairs or escalators while using the rollator.Do not use on inclines over 8%.Job specs attached.Page 2 shows the warning label stating the following: "warning, this is a walking aid only and is not to be used as a transportation device.Weight capacity 300 lbs." page 4 shows the location placement for all labels on the frame and shows the location where the hangtag is to be attached.

• Brand Name: ROSCOE
• Type of Device: E-SERIES ROLLATOR
• 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: 17556167
• MDR Text Key: 321238590
• Report Number: 3012316249-2023-00029
• 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: 08/16/2023

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: 30164
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/16/2023
• Distributor Facility Aware Date: 07/24/2023
• Event Location: Other
• Date Report to Manufacturer: 08/16/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female