MAUDE Adverse Event Report: BLISS HEALTH PRODUCTS DRIVE; BATH BENCH

Model Number	12029-2
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Fall (1848)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath bench by a distributor, who reported that "the legs are not sturdy, and the patient fell off the bench twice, last time had to go to the hospital." the device was not returned for evaluation, and the patient did not respond to attempts at contact to gather more information.

• Brand Name: DRIVE
• Common Device Name: BATH BENCH
• Manufacturer (Section D): BLISS HEALTH PRODUCTS; 61 & 96 zhaoyi rd; dongsheng town; zhongshan city, guangdong 52841 4; CH 528414
• MDR Report Key: 14980902
• Report Number: 2438477-2022-00044
• Device Sequence Number: 5631313
• Product Code: ILS
• UDI-Device Identifier: 50822383110597
• UDI-Public: 50822383110597
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/11/2022
• Report Date (Section F): 07/11/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 12029-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2022
• Device Age: 1 YR
• Date Report to Manufacturer: 06/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/11/2022