MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; ROLLATOR, KNOCK DOWN, WGNS

Catalog Number	WRX490530
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the rollator brakes disengaged as the end-user was getting up from a bedside commode.The end-user fell onto wood laminate flooring, was assisted back up by a family member, and brought to a local hospital's emergency department (ed).An unspecified x-ray was obtained in the ed and the end-user was diagnosed with an unspecified femur fracture.The end-user received unspecified pain medication in the ed and surgical intervention for the reported femur fracture.She was admitted to the hospital for five (5) days and was then admitted to a rehabilitation facility for twenty (20) days.No additional medical intervention or follow-up care was reported to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported femur fracture, hospital admission, and rehabilitation facility admission, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the rollator brakes disengaged and the end-user experienced a fall.

• Common Device Name: ROLLATOR, KNOCK DOWN, WGNS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 9671579
• Report Number: 1417592-2020-00005
• Device Sequence Number: 10863044
• Product Code: ITJ
• UDI-Device Identifier: 00311917203065
• UDI-Public: 00311917203065
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2020

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: WRX490530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/05/2020
• 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: Hospitalization; Required Intervention; Disability
• Patient Weight: 36