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

Catalog Number MDS86850EP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 08/31/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer on (b)(6) 2023 they were walking with the device when it "moved forward too fast and i fell on the tile".Per the customer the device "did not seem to malfunction, it just moves very easily".Per the customer they went to the emergency room due to the pain at a later date and were diagnosed with a broken femur which required surgery.No additional information is available at this time.The sample was requested for evaluation.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 the device when it "moved forward too fast and i fell on the tile".

• Type of Device: ROLLATOR,BASIC,PURPLE
• 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: 18004525
• MDR Text Key: 326501962
• Report Number: 1417592-2023-00425
• 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: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: MDS86850EP
• Device Lot Number: 05422120001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/04/2023
• 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