MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ROLLATOR; WALKER, MECHANICAL

Model Number MDS86845BLKM

Device Problem Unstable (1667)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

I purchased a medline premium rollator wheeled walker for my (b)(6) yo mother.After assembly following all enclosed instructions for use, i discovered that if the user sits on the device as instructed, it results in a very unstable seating position that could easily result in a potentially fatal head injury from backwards fall.There are four wheels on the device, two of which are caster-type to allow turning.If the user comes to a stop, engages the brakes, then sits down on the seat, the user's center of gravity is outside the four wheels.This results in a tipping hazard, and the user will fall backwards, resulting head injury.To mitigate this risk, the user should first come to a stop, then pull the device backward until the front caster wheels turn 180-degrees around, then engage brakes, then sit.This results in the user's center of gravity falling within the footprint of the four wheels -- a much more stable sitting position.Fda safety report id# (b)(4).

• Brand Name: ROLLATOR
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10689726
• MDR Text Key: 211901873
• Report Number: MW5097259
• Device Sequence Number: 1
• Product Code: ITJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDS86845BLKM
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR