MAUDE Adverse Event Report: ZHONGSHAN LEBORN MEDICAL CO LTD DRIVE; COMMODE TRANSFER BENCH

Model Number	12011KDC-1
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Fall (1848); Head Injury (1879); Neck Pain (2433)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a transfer bench by service of a lawsuit.The lawsuit alleges that while the patient was using the transfer bench, the leg broke, causing him to fall backwards and his neck to move forward.The end user alleges that a myriad of serious injuries, including quadriplegia, resulted from the accident, but information uncovered during the lawsuit has suggested that he was already quadriplegic and using a wheelchair prior to the accident.Drive is defending the lawsuit and is limited to the investigation possible through the lawsuit.

• Brand Name: DRIVE
• Common Device Name: COMMODE TRANSFER BENCH
• Manufacturer (Section D): ZHONGSHAN LEBORN MEDICAL CO LTD; chuang zhan road, xinsheng ind; dong chen rd.,dongsheng town; zhongshan, guangdong 52841 4; CH 528414
• MDR Report Key: 17879577
• Report Number: 2438477-2023-00116
• Device Sequence Number: 18085112
• Product Code: ILS
• UDI-Device Identifier: 00822383231129
• UDI-Public: 00822383231129
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/05/2023
• Report Date (Section F): 10/05/2023

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: 12011KDC-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/27/2023
• Event Location: Home
• Date Report to Manufacturer: 10/16/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2023
• 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 Sex: Male
• Date Report Sent to FDA: 10/05/2023