MAUDE Adverse Event Report: COMBO (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD. DRIVE; WALKER, MECHANICAL

Model Number	10257BL-1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Concussion (2192)
Date of Event	01/04/2025
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 while trying to use the device to support herself while rising from a seated position, the unit went sideways, causing her to fall and resulting in a concussion and bruising on her face, neck, head.She specifically reported that because she does not remember the moment when she fell, she does not know if the device malfunctioned and caused the fall.After the fall, the device was found to have a bent wheel with a cracked spoke, but it was unclear whether this condition existed before or as a result of the incident.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 (ZHONG SHAN) MEDICAL EQUIPMENT CO.,LTD.; no.6 tongxing east road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 21327227
• Report Number: 2438477-2025-00011
• Device Sequence Number: 12794273
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: (01)00822383290331
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/06/2025
• Report Date (Section F): 02/06/2025

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?: No
• 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: 01/14/2025
• Device Age: 2 YR
• Event Location: Home
• Date Report to Manufacturer: 02/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2025
• 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: Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Date Report Sent to FDA: 02/06/2025