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

Catalog Number MDS86800XWS

Device Problem Unintended Collision (1429)

Patient Problem Head Injury (1879)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

Complaint received 12/22/2020, reported by an attorney, that an (b)(6) female on "(b)(6) 2020 end-user concluded treatment at (b)(6) dialysis clinic at (b)(6) hospital.Dialysis tech had the end-user sit in the rollator and push her towards the lobby.When the rollator made contact with a floor mat both end-user and the rollator fell to the floor.End-user struck her head on the terrazo floor causing multiple head injuries including a subdural hematoma." no further information available at this time.Due to the reported incident 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.

Event Description

It was reported by an attorney, the end-user was being pushed while sitting on a rollator.The rollator made contact with a floor mat and the end-user fell to the floor incurring head injuries.

• 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: 11100980
• MDR Text Key: 224553977
• Report Number: 1417592-2020-00157
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/31/2020

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: Health Professional
• Device Catalogue Number: MDS86800XWS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 12/31/2020
• 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: 81 YR
• Patient Weight: 104