MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS CO., LTD. DRIVE; BATH CHAIR

Model Number	RTL12203KDR
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Head Injury (1879)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath bench by an end user, who stated that the "front legs started to spread." the end user reportedly fell and sustained a head injury that developed into a large bruise.The end user reportedly called an emergency room for treatment, and was advised to stay home and watch for signs of a concussion.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): BLISS HEALTH PRODUCTS CO., LTD.; no.61 & no.96, zhaoyi road; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 17398371
• Report Number: 2438477-2023-00106
• Device Sequence Number: 7572284
• Product Code: ILS
• UDI-Device Identifier: 00822383246253
• UDI-Public: 822383246253
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/26/2023
• Report Date (Section F): 07/26/2023

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: RTL12203KDR
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/26/2023
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 07/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2023
• 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: Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 87 KG
• Date Report Sent to FDA: 07/26/2023