MAUDE Adverse Event Report: HEBEI HEALTHPLUS MEDICAL ROSCOE; WALKER, MECHANICAL

Model Number 30164

Device Problem Human-Device Interface Problem (2949)

Patient Problem Insufficient Information (4580)

Event Date 06/14/2021

Event Type  Injury  

Event Description

(b)(6) 2023: clear counsel law group represents *** in a claim for damages for the injuries resulting from a rollator falling over while she sat on it which occurred on or about (b)(6) 2021, on or near mandalay bay, las vegas.(b)(6) 2023: this is a case wherein compass health brands and invacarecorporation, inc (hereinafter "the rollator defendants") designed, manufactured and marketed a rol lator or wheeled walker that is prone to suddenly and unexpectedly tipping, ejecting its passenger to the ground.Because the rollator defendants market to the elderly and infirm, the most vulnerable people in our society are being put at risk.In this particular case, an elderly woman, ****, was severely injured as a result of the unreasonably unsafe product.25.The rollator defendants designed and/or manufactured and/or sold rollator bearing item #30164 as a product intended for mobility assistance (the "rollator").39.The rollator defendants intended that the rollator be used as a mobile chair that can be pushed without a passenger to a location and then used by the consumer as a chair.40.It is hazardous to use the rollator as a transport chair because it has the propensity to tip when used as a transport chair.49.The rollator defendants knew that if a person falls while using the rollator, the person has a risk of head injury when the person hits the ground or nearby objects.52.The rollator defendants should have anticipated that consumers of their product would use the product as a transport chair.53.The rollator defendants anticipated that certain of their consumers would use the product as a transport chair if not properly warned of the hazards of using the product as a transport chair.58.The rollator defendants should have anticipated that even with warnings, certain consumers would use the product as a transport chair and that safety features were necessary to prevent injury from the foreseeable use of using the rollator as a transport chair.68.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.76.At all times relevant, the walkway contained a divot, pothole, unsafe lip, or crater that created a hazardous condition and trip hazard, and is below community safety standards.80.On or around june 14, 2021, plaintiff was on the walkway in the pool area at mandalay bay while using the rollator.81.While in the pool area with her daughter and granddaughter, approaching the handicap ramp, the wheels of plaintiff's rollator caught on the hazardous condition in the flooring.82.The defective design of the rollator, combined with the hazardous condition of the flooring, caused the rollator to tip unsafely and caused plaintiff to tip and fall from the rollator.86.The rollator tipping and ejecting plaintiff caused severe damage to plaintiff, including, but not limited to, head injury, neck injury, back injury, loss of vision, other medical injuries and pain and suffering.99.As a direct and proximate result of her injuries, plaintiff has suffered both medical costs and pain and suffering.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: WALKER, MECHANICAL
• 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: 17265665
• MDR Text Key: 318565115
• Report Number: 3012316249-2023-00024
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/06/2023

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?: Yes
• 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: 07/06/2023
• Distributor Facility Aware Date: 06/26/2023
• Event Location: Other
• Date Report to Manufacturer: 07/06/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female
• Patient Weight: 135 KG