MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Walgreens; ROLLATOR, KNOCK DOWN, WGNS

Model Number	490530
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the left back wheel was loose and the end user lost her balance resulting in a fall that caused a fracture to the right humorous and required surgical intervention.
Additional Manufacturer Narrative
It was reported by the end users spouse that the left back wheel was loose and the end user lost her balance resulting in a fall that caused a fracture to the right humorous and required surgical intervention.According to the spouse, his wife was walking outside and when she was just 3 steps outside the door he saw her falling into a brick wall.According to the spouse an ambulance was called and transported the end user to the hospital.The end user underwent a full assessment with x-rays and computed tomography (ct) scan and was found to have a fractured right humorous.The end user had surgery on (b)(6) 2021 to repair the injury and is being transferred to a rehab facility for strength training.The spouse reported that he returned the device to the retail store for a replacement and the device is not available to return for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

• Brand Name: Walgreens
• Common Device Name: ROLLATOR, KNOCK DOWN, WGNS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13101122
• Report Number: 1417592-2021-00231
• Device Sequence Number: 17290470
• Product Code: ITJ
• UDI-Device Identifier: 00311917203065
• UDI-Public: 00311917203065
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/28/2021

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 Model Number: 490530
• Device Catalogue Number: WRX490530
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 77 KG