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

Model Number	RTL12203KDR
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	03/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a shower chair by an end user who stated that "the chair collapsed under their weight, and they hit their head and foot while in the shower." the end user did not seek 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: SHOWER 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: 16643404
• Report Number: 2438477-2023-00021
• Device Sequence Number: 20206424
• Product Code: ILS
• UDI-Device Identifier: 00822383246253
• UDI-Public: 822383246253
• 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): 03/30/2023
• Report Date (Section F): 03/30/2023

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: 03/07/2023
• Device Age: 4 MO
• Date Report to Manufacturer: 04/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/30/2023
• 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: 98 KG
• Date Report Sent to FDA: 03/30/2023