MAUDE Adverse Event Report: DRIVE; BATH STOOL

Model Number	RTL12004KD
Medical Device Problem Code	Material Integrity Problem (2978)
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 stool by an end user, who stated that "i leaned back to reach for something that was behind me and the leg gave way, completely bent.I fell back landing on my back and then then hit my head." the end user reports having had back surgery, and continued treatment with a chiropractor.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: BATH STOOL
• MDR Report Key: 15576915
• Report Number: 2438477-2022-00097
• Device Sequence Number: 12453353
• Product Code: ILS
• UDI-Device Identifier: 00822383246581
• UDI-Public: 00822383246581
• 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): 10/10/2022
• Report Date (Section F): 10/12/2022

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?: Yes
• Device Model Number: RTL12004KD
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/12/2022
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 10/12/2022