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

Catalog Number : MDS86800XWS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Head Injury (1879)

Event Date 01/10/2022

Event Type  Injury  

Event Description

It was reported by the customer that he fell to the ground while self-propelling in a rollator while in a seated position resulting in a head injury.

Manufacturer Narrative

It was reported by the customer that he fell to the ground while self-propelling in a rollator while in a seated position resulting in a head injury.Per customer, "he hit a bump at the end of the driveway that threw him off the rollator onto the ground." per the customer, "after the fall he noticed that the front left wheel was bent as well as the bolt that holds the fork onto the device." per the customer, "he laid on the concrete until ambulance arrived and was transferred to the hospital for evaluation, ct scan was performed which showed a brain bleed and after 8 hours an additional ct scan was performed which did not show an increase in bleeding, customer was discharged home with no additional injuries noted." the sample is not available to be returned for evaluation.No additional information is available.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.

• Type of Device: ROLLATOR, BARIATRIC, BASIC STEEL
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13535824
• MDR Text Key: 285639931
• Report Number: 1417592-2022-00014
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/15/2022

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: 88521080003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/15/2022
• 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): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 159 KG