MAUDE Adverse Event Report: DRIVE; TRANSFER BENCH

Model Number	12005KD-1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	12/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a bath transfer bench by an attorney, who stated that "the end user sat on the shower chair and the back rest broke off, causing him to fall backwards and land directly on his head." the end user went to the er, where he was reportedly diagnosed with a concussion.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
• MDR Report Key: 16388829
• Report Number: 2438477-2023-00008
• Device Sequence Number: 5113996
• Product Code: ILS
• UDI-Device Identifier: 00822383225555
• UDI-Public: 822383225555
• Combination Product (Y/N): N
• 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): 02/16/2023
• Report Date (Section F): 02/02/2023

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: 12005KD-1
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/27/2023
• Date Report to Manufacturer: 02/09/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/16/2023
• 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: Hospitalization
• Patient Age: 37 YR
• Patient Sex: Male
• Date Report Sent to FDA: 02/02/2023