MAUDE Adverse Event Report: NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD. DRIVE; WALKER, MECHANICAL

Model Number	R726BL
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
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's daughter, who stated that the back left leg of the rollator broke while in use, causing the end user to fall.The fall reportedly resulted in bruises on her tailbone, arm and back, and a fifth metatarsal fracture in her foot, requiring a stabilizing shoe for her foot.Drive devilbiss healthcare is currently investigating the incident, including requesting the return of the device for evaluation, and an update will be filed if additional information becomes available.
Additional Manufacturer Narrative
Drive devilbiss healthcare previously reported the incorrect manufacturer name and address in section d3 and f14.The information has been updated in these sections to reflect the correct manufacturer name and address.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): NINGBO SHENYU MEDICAL EQUIPMENT CO.,LTD.; 1318 west of tanjialing road; west district; yuyao, zhejiang 52840 0; CH 528400
• MDR Report Key: 18238253
• Report Number: 2438477-2023-00145
• Device Sequence Number: 19639744
• Product Code: ITJ
• UDI-Device Identifier: 00822383233208
• UDI-Public: 00822383233208
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 12/01/2023
• Report Date (Section F): 12/01/2023

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: R726BL
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/02/2023
• Event Location: Other
• Date Report to Manufacturer: 12/01/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/01/2023
• 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: 12/01/2023