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

Model Number	12011KD-1A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879); Loss of consciousness (2418)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a transfer bench by an end user's wife, who stated that "her husband was on the transfer bench when the leg snapped.He fell and hit his head and became unconscious for a couple of minutes." 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: TRANSFER 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: 16421611
• Report Number: 2438477-2023-00016
• Device Sequence Number: 17738653
• Product Code: ILS
• UDI-Device Identifier: 00822383004655
• UDI-Public: 00822383004655
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 02/22/2023
• Report Date (Section F): 02/22/2023

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: 12011KD-1A
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/13/2023
• Device Age: 6 MO
• Date Report to Manufacturer: 03/01/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2023
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 134 KG
• Date Report Sent to FDA: 02/22/2023