MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE DEVILBISS HEALTHCARE; WALKER, MECHANICAL

Model Number	R726BK
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/05/2023
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 reported that the front wheels continued to move while the brakes were locked.The end user did not fall, but reported that because she continued to hold onto the rollator when it was moving, she experienced a sharp pain in her previously replaced elbow and was diagnosed with a complex fracture and referred to an elbow specialist.Drive devilbiss healthcare is currently investigating the incident, however the end user refused to return 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): COM-DA HEALTHCARE CO.,LTD; unit 3 no.94 dongcheng road,; dong sheng town; zhong shan city, guang dong province 52840 0; CH 528400
• MDR Report Key: 18230791
• Report Number: 2438477-2023-00142
• Device Sequence Number: 17525779
• Product Code: ITJ
• UDI-Device Identifier: 00822383240664
• UDI-Public: 822383240664
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 11/29/2023
• Report Date (Section F): 11/29/2023

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: R726BK
• Device Catalogue Number: R726BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2023
• Event Location: Home
• Date Report to Manufacturer: 11/29/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2023
• 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: Other
• Patient Age: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 11/29/2023