MAUDE Adverse Event Report: COMBO (ZHONGSHAN) MEDICAL EQUIPMENT DRIVE; WALKER, MECHANICAL

Model Number	10257BL-1
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Brain Injury (2219)
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 the front left fork/caster assembly bent while in use causing her to fall and hit her head on the pavement resulting in a brain bleed, hospital stay and rehabilitation.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): COMBO (ZHONGSHAN) MEDICAL EQUIPMENT; no.6 tongxing east road; dongsheng town; zhongshan, guangdong 52841 4; CH 528414
• MDR Report Key: 19393663
• Report Number: 2438477-2024-00027
• Device Sequence Number: 15394055
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 00822383290331
• 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): 05/24/2024
• Report Date (Section F): 05/24/2024

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: 10257BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/29/2024
• Event Location: Other
• Date Report to Manufacturer: 05/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2024
• 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; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 118 KG
• Date Report Sent to FDA: 05/24/2024