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

Model Number	146-10257BL-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a rollator by an end user's child, who stated that "the wheel fell off while my mother was walking." there was no report or evidence of illness, injury or medical treatment associated with the complaint.Multiple attempts were made to retrieve the product for investigation, with no response.Drive will continue to monitor complaints for any related trends.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• 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: 17002176
• Report Number: 2438477-2023-00056
• Device Sequence Number: 6286128
• Product Code: ITJ
• UDI-Device Identifier: 00612479223158
• UDI-Public: 00612479223158
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2023
• Report Date (Section F): 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 146-10257BL-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/24/2023
• Date Report to Manufacturer: 06/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 05/25/2023