MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR, BARIATRIC, BASIC STEEL

Catalog Number MDS86800XWS

Device Problem Device Fell (4014)

Patient Problem Bruise/Contusion (1754)

Event Date 03/07/2021

Event Type  malfunction  

Manufacturer Narrative

Email received by end user, who provided additional information in regards to this incident.End user reports, on 3/7/2021 while "in route from my bedroom to the kitchen the left rear wheel and axle gave way me to fall." end causing user reports, "i hit the back of my head and upper body as well as my back." end user reports going to the emergency room, toledo hospital where x-rays were taken of his cervical, thorax and lumbar areas.End user reports the following injuries, "hurting in the right shoulder, lumbar and thorax areas.Deep contusions on rib cage area and shoulder.Rotator rupture has limited his right arm to less than 30% usage." end user reports he was discharge that same day 3/7/2021, no report of follow-up physician visit.End user reports, treatment prescribed "ice and heat in 20-minute intervals." end user further reports he was given a replaced rollator once before.Upon further investigation, it was noted the end user received a replacement rollator 10/1/2019 for a "stripped frame" on sales order 492404855.Photographs have been received by end user and evaluation by the division is complete (see below).Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.Division qa investigation: 03/18/2021 15:36:26 cst "after viewing the photos of the rollator, the customer complaint has been confirmed.The rollator appears to be in used condition.In the photo, you will see that the rear wheel is very crooked.It appears that either the bearings or the axle itself is damaged.There appears to be no other signs of damage, abuse, or misuse.We do not need the sample returned.The division will monitor through quarterly trending.".

Event Description

It was reported, end user fell as the result of the axle failing on the left rear wheel.End user reports going to the emergency room for x-rays.

• Type of Device: ROLLATOR, BARIATRIC, BASIC STEEL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11572643
• MDR Text Key: 246059269
• Report Number: 1417592-2021-00048
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2021

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 Catalogue Number: MDS86800XWS
• Device Lot Number: 88519080002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 120