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

Model Number 12011KD-1A

Device Problem Fracture (1260)

Patient Problems Fall (1848); Head Injury (1879); Loss of consciousness (2418)

Event Type  Injury  

Event 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
• Type of Device: 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
• MDR Text Key: 310040179
• Report Number: 2438477-2023-00016
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383004655
• UDI-Public: 00822383004655
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 12011KD-1A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2023
• Distributor Facility Aware Date: 02/13/2023
• Device Age: 6 MO
• Date Report to Manufacturer: 03/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 134 KG