MAUDE Adverse Event Report: CC HSING COMPANY LIMITED DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

Model Number	RTL10266CF
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by the end user, who stated that the rear wheel fell off, causing her to fall and hit her shoulder and head on the kitchen table.Paramedics responded to the scene but the end user refused to go to the hospital.The end user was eventually diagnosed by her physician with a torn deltoid muscle in her left arm and an injury to her quadricep muscle, and is receiving physical therapy.Drive devilbiss is currently investigating the incident, including attempting to retrieve the device for evaluation.An update will be filed if additional information becomes available.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): CC HSING COMPANY LIMITED; no. 1 benting; bentsuo village, sikao chiayi 26989 61; TW 2698961
• MDR Report Key: 18291682
• Report Number: 2438477-2023-00148
• Device Sequence Number: 6667639
• Product Code: ITJ
• UDI-Device Identifier: 00822383576817
• UDI-Public: 822383576817
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/08/2023
• Report Date (Section F): 12/08/2023

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: RTL10266CF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/13/2023
• Event Location: Home
• Date Report to Manufacturer: 12/08/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/08/2023
• 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 Sex: Female
• Date Report Sent to FDA: 12/08/2023