MAUDE Adverse Event Report: COM-DA HEALTHCARE CO., LTD PROBASICS; 8" BLUE BARI ROLLATOR

Model Number RLAB8BL

Device Problem Use of Device Problem (1670)

Patient Problems Bruise/Contusion (1754); Concussion (2192)

Event Date 01/09/2023

Event Type  Injury  

Event Description

The caregiver was pushing the user in the rollator on a concrete sidewalk and pushing up a hill when there was about a 4 foot wide by 2 foot wide hole and they were unable to avoid it.They hit the hole and the caregiver and user fell.The right hand brake system and back bracket holders have broken on it and caregiver said these parts are needed.User had slight concussion, and received bruises to her hips.And legs.She went to the hospital for x rays but they were negative.He said the serial # sticker has been worn off and not able to read it.User weight about 250lbs.On (b)(6) 2023 date of accident.Initial reporter states the incident occurred but no fault of the device at all.He was behind her, walking with her, was turning her around and he pulled her and he started falling and then they both fell.States her 400 lbs.And whole width of the walker fell in the hole and then the walker folded up.When she fell the device broke, the frame is good though.The back brackets broke/cracked and another broke this morning, it was already cracked and finished breaking.The hole tripped him then he pulled her/turned her around, was pushing her up a hill and didn't see the hole.Their whole bodies fell in it.Said it occurred in front of anything medical on sidewalk.States the serial # sticker is all rubbed out.User manual attached.Page 7, 2nd warning: "never use near steps, sloped driveways, hills, and/or ramps with a steep incline (never greater than 15 degrees)." 4th warning: "always take additional care and move slowly when moving from carpeted to hard surface floors or cracks/separations in walk way surfaces; avoid bumps, drainage gates, and sudden surface changes.Rollator may abruptly stop if a wheel becomes wedged." page 7, last warning: "do not sit on the rollator if it is parked on a slope.Only use the seat on level ground." page 8, 3rd warning: always engage both parking brakes before sitting in the rollator.Do not move or scoot while seated in the rollator.Parking brakes must remain engaged at all times while seated.Ensure the front wheels are in the forward position before transferring into or out of the seat.Do not use the rollator as a wheelchair or transport device.This is a walking aid only.Never scoot, roll, or propel device while seat is occupied." 4th warning: "do not attempt to reach objects that are out of your immediate reach while seated on the rollator.Do not lean forward, backward, or to either side while seated on the rollator." page 9, 6th bulletin: "be aware of your surroundings when operating the rollator.Look for hazards and avoid them.Avoid streets and surfaces with water, sand, gravel, dirt, leaves, and other debris.Wet, slick, uneven, and/or rough surfaces may impair traction and contribute to possible accidents.Loose cords and unsecured rugs may move suddenly and cause a loss of balance.Do not use a rollator in mud, ice, or puddles." 7th bulletin: "never use near steps, sloped driveways, hills, and/or ramps with a steep incline (never greater than 15 degrees)." 9th bulletin: "always take additional care and move slowly when moving from carpeted to hard surface floors or cracks/separations in walk way surfaces; avoid bumps, drainage gates, and sudden surface changes.Rollator may abruptly stop if a wheel becomes wedged." 11th bulletin: "do not sit on the rollator if it is parked on a slope.Only use the seat on level ground." page 10, 2nd bulletin: "always engage both parking brakes before sitting in the rollator.Do not move or scoot while seated in the rollator.Parking brakes must remain engaged at all times while seated.Ensure the front wheels are in the forward position before transferring into or out of the seat." 3rd bulletin: "do not use the rollator as a wheelchair or transport device.This is a walking aid only.Never scoot, roll, or propel device while seat is occupied." 4th bulletin: "do not attempt to reach objects that are out of your immediate reach while seated on the rollator.Do not lean forward, backward, or to either side while seated on the rollator." page 11: "this product should not be used without the instruction of a healthcare professional.Failure to use common sense and heed the above warnings further increases risk of serious injury.Use at your own risk and with appropriate and serious attention to safe operation.Use caution.".

• Brand Name: PROBASICS
• Type of Device: 8" BLUE BARI ROLLATOR
• Manufacturer (Section D): COM-DA HEALTHCARE CO., LTD; no. 1, jinzhao street, west di; no. 6 workshop ii; zhongshan city guangdong, cn ; CH
• MDR Report Key: 17106094
• MDR Text Key: 317117903
• Report Number: 3012316249-2023-00018
• 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: 06/12/2023

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: RLAB8BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2023
• Distributor Facility Aware Date: 05/22/2023
• Date Report to Manufacturer: 06/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Weight: 113 KG