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

Model Number	RTL12032KDR
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	04/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a transfer bench by an end user's mother, who stated that "the chair fell backwards while my son was showering.He hit his head on the shower wall as he fell backwards," reportedly causing a "lump on his head." there was no medical treatment sought.Upon follow up with the end user's mother, she reported that "not all suction cups were installed on the unit." they were later installed, and she will continue to use the unit.Drive will continue to monitor complaints for any related trends.

• 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: 16994666
• Report Number: 2438477-2023-00045
• Device Sequence Number: 3455294
• Product Code: ILS
• UDI-Device Identifier: 00822383001432
• UDI-Public: 00822383001432
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/24/2023
• Report Date (Section F): 05/24/2023

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: RTL12032KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2023
• Device Age: 9 MO
• Event Location: Home
• Date Report to Manufacturer: 05/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 101 KG
• Date Report Sent to FDA: 05/24/2023