MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR,SUPER LIGHT,250LB CAP.

Catalog Number	WRX449724
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that end-user stood up and began to walk on a rug surface when the unidentified wheel of the rollator came off.The end-user fell, emergency medical service was called and end-user was taken to a hospital.The end-user reportedly sustained a right femur fracture, which required a 12-inch plate and a fixator implanted.The end-user is doing rehab at an assisted living facility.The rollator was reportedly used for approximately five months prior to this event occurring.Due to the reported femur fracture and required medical intervention, this medwatch is being filed.The sample is not available to be returned for evaluation.A root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the rollator's wheel came off while end-user was walking using the rollator.The end-user fell and sustained right femur fracture.

• Common Device Name: ROLLATOR,SUPER LIGHT,250LB CAP.
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 8821386
• Report Number: 1417592-2019-00104
• Device Sequence Number: 3027052
• Product Code: ITJ
• UDI-Device Identifier: 10311917124718
• UDI-Public: 10311917124718
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: WRX449724
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 88