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

Model Number	146-11148-1
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	02/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) was notified of an incident involving a bath chair by an end user's caregiver, who stated that the "legs of the chair collapsed, and the end user fell and hit her head on her rollator." the end user did not seek any medical attention.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: BATH CHAIR
• 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: 16725254
• Report Number: 2438477-2023-00027
• Device Sequence Number: 7949990
• Product Code: ILS
• UDI-Device Identifier: 00612479222069
• UDI-Public: 612479222069
• 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): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/12/2023
• Report Date (Section F): 04/12/2023

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: 146-11148-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/20/2023
• Date Report to Manufacturer: 04/19/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2023
• 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: 04/12/2023