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	10/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user, who stated that the brakes failed, reportedly causing her to fall and break her ankle.The end user did not provide any information regarding medical treatment.Repeated attempts to gather additional information and to have the device returned for investigation were unsuccessful.If pertinent information becomes available, drive will file an addendum to this report.

• Brand Name: DRIVE DEVILBISS HEALTHCARE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): COM-DA HEALTHCARE CO.,LTD; 1 jinshao street; west district; zhongshan city, guang dong province 52840 0; CH 528400
• MDR Report Key: 17968512
• Report Number: 2438477-2023-00134
• Device Sequence Number: 7623821
• Product Code: ITJ
• UDI-Device Identifier: 00822383240664
• UDI-Public: 822383240664
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/19/2023
• Report Date (Section F): 10/19/2023

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: 10/19/2023
• Event Location: Home
• Date Report to Manufacturer: 10/19/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2023
• 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 Sex: Female
• Date Report Sent to FDA: 10/19/2023