MAUDE Adverse Event Report: DRIVE; BATH STOOL

Model Number RTL12004KD

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Type  Injury  

Event 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
• Type of Device: BATH STOOL
• MDR Report Key: 15576915
• MDR Text Key: 301497707
• Report Number: 2438477-2022-00097
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383246581
• UDI-Public: 00822383246581
• 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: 10/12/2022,10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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
• Date Report Sent to FDA: 10/12/2022
• Distributor Facility Aware Date: 09/12/2022
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female