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

Model Number	10257BL-1
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by a letter from an attorney, which alleges that "the folding hinge assembly of the rollator failed as the end user sat down on the device's seat," causing the end user to fall backwards.The attorney further alleges that as a result, the end user "broke his back" and has been in a back brace since the incident.Drive devilbiss healthcare is currently investigating the incident, including attempting to inspect the product through the attorney.An update will be filed if additional information becomes available.

• 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: 18348331
• Report Number: 2438477-2023-00150
• Device Sequence Number: 6268584
• Product Code: ITJ
• UDI-Device Identifier: 00822383290331
• UDI-Public: 00822383290331
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/18/2023
• Report Date (Section F): 12/18/2023

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: 10257BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/05/2023
• Event Location: Other
• Date Report to Manufacturer: 12/18/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/18/2023
• 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: Male
• Date Report Sent to FDA: 12/18/2023