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

Catalog Number MDS86800XWS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 08/02/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer on (b)(6) 2023 they were walking with their rollator outside, and after becoming "winded" the customer went to sit down on the locked device when "after a few minutes the wheel started to give away causing the device to fold up around their legs".Per the customer they were given diclofenac for the pain and were referred to physical therapy due to the fall.The device was purchased from amazon in (b)(6) 2022.The device has been requested for evaluation.No additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, 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 they were walking with their rollator outside, and after becoming "winded" the customer went to sit down on the locked device when "after a few minutes the wheel started to give away causing the device to fold up around their legs".

• Type of Device: ROLLATOR, BARIATRIC, BASIC STEEL
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17632569
• MDR Text Key: 322069279
• Report Number: 1417592-2023-00354
• 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: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86800XWS
• Device Lot Number: 88521100001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/03/2023
• 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