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

Model Number	12011KD-1
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879)
Date of Event	05/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a bath bench by an end user's daughter, who stated that her father "fell off the chair and hit his head." there were no additional details as to the nature of the injury or product malfunction.There was no report or evidence of medical treatment associated with the complaint.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 BENCH
• 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: 17167197
• Report Number: 2438477-2023-00086
• Device Sequence Number: 17578687
• Product Code: ILS
• UDI-Device Identifier: 00822383224916
• UDI-Public: 822383224916
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 06/20/2023
• Report Date (Section F): 06/20/2023

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: 12011KD-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/25/2023
• Date Report to Manufacturer: 06/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/20/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 111 KG
• Date Report Sent to FDA: 06/20/2023