MAUDE Adverse Event Report: COM-DA HEALTHCARE CO.,LTD DRIVE; BATH CHAIR

Model Number	RTL12505
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath bench by an end user, who stated that one of the legs of the unit "snapped off," which reportedly caused her to "fall over the tub" and "[injure] entire right side." the end user reportedly treated her injury with ice packs and lidocaine patches.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): COM-DA HEALTHCARE CO.,LTD; no. 1, jinzhao street, west di; no. 6 workshop ii; zhongshan city, guangdong ; CH
• MDR Report Key: 17209749
• Report Number: 2438477-2023-00067
• Device Sequence Number: 20499856
• Product Code: ILS
• UDI-Device Identifier: 00822383247151
• UDI-Public: 00822383247151
• 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
• Type of Report: Initial
• Report Date (Section B): 06/27/2023
• Report Date (Section F): 06/15/2023

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: RTL12505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2023
• Device Age: 3 YR
• Date Report to Manufacturer: 06/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2023
• 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: 06/15/2023