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

Catalog Number MDS86800XWS

Device Problem Break (1069)

Patient Problems Headache (1880); Concussion (2192)

Event Date 06/27/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, on (b)(6) 2023 while sitting in the rollator the "left rear wheel broke off" causing him to fall backwards "striking his head on the concrete".The customer reported he began having "headaches" after the reported incident and was later diagnosed with a "concussion".Sample was requested for return evaluation.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, on (b)(6) 2023 while sitting in the rollator the "left rear wheel broke off" causing him to fall backwards "striking his head on the concrete".

• Type of Device: ROLLATOR, BARIATRIC, BASIC STEEL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17546211
• MDR Text Key: 321148019
• Report Number: 1417592-2023-00337
• 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: 08/14/2023

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86800XWS
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/14/2023
• 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