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

Model Number MDS86850ESKD

Device Problem Component Missing (2306)

Patient Problems Bruise/Contusion (1754); Fall (1848); Skin Tears (2516)

Event Date 08/03/2020

Event Type  Injury  

Event Description

A defect of a rollator walker made by medline.This rollator walker caused my patient to fall backwards while she was sitting in it with the brakes on.My patient was fortunate that she acquired only some bruising on back of head and a skin tear on her left lower leg.When i examined the walker, i found that the left front wheel was separated completely from the rest of the walker.When i examined the opposing swiveling wheel on the right side, i found out that it was about to come off too.Apparently there was a pin that holding the wheels from being unscrewed out of the walker's shaft.These pins are not present on either side.I am urging that this walker pulled off the market immediately.Model number mds86850eskd.Fda safety report id# (b)(4).

• Brand Name: MEDLINE ROLLATOR WALKER
• Type of Device: MECHANICAL WALKER
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10401017
• MDR Text Key: 202909952
• Report Number: MW5096055
• 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: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MDS86850ESKD
• Device Lot Number: 88517110003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 47