MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH BENCH

Model Number RTL12203KDR

Device Problem Collapse (1099)

Patient Problems Fall (1848); Easy Bruising (4558)

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a bath bench.The device will not been returned for evaluation.The user's wife said she would send photos which have not been received.We are filing this report in an over-abundance of caution.The end-user had total knee surgery.He used the device once before the surgery.When he went to use the chair again after surgery the legs bent and came apart causing him to fall to the floor.He hit his head and bruised his leg.They had to call the fire department to get him up.His doctor advised him that there were injuries and bruising due to the fall.No additional medical information is available.

• Brand Name: DRIVE
• Type of Device: BATH BENCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12620564
• MDR Text Key: 280595893
• Report Number: 2438477-2021-00054
• Device Sequence Number: 1
• Product Code: ILS
• UDI-Device Identifier: 00822383246253
• UDI-Public: 822383246253
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: RTL12203KDR
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/12/2021
• Event Location: Home
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1