MAUDE Adverse Event Report: DRIVE; BATH SAFETY STOOL

Model Number RTL12004KD

Device Problem Material Integrity Problem (2978)

Patient Problems Bruise/Contusion (1754); Fall (1848)

Event Date 02/08/2021

Event Type  Injury  

Event Description

On february 2, 2022, drive devilbiss healthcare received notice of an accident involving a bath safety stool.The end user's attorney reported that the end user was sitting on the unit when one of the legs "broke off," although photographs indicate that one of the legs bent.The attorney reported that the end user was injured and sought medical attention, and provided photographs of bruising on the end user's lower leg and angle.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 SAFETY STOOL
• MDR Report Key: 14024807
• MDR Text Key: 288696127
• Report Number: 2438477-2022-00031
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383246581
• UDI-Public: 822383246581
• 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: 04/06/2022

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 Operator: Lay User/Patient
• Device Model Number: RTL12004KD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/06/2022
• Distributor Facility Aware Date: 02/02/2022
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 96 KG