MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH BENCH

Model Number	RTL12203KDR
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Codes	Fall (1848); Easy Bruising (4558)
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: BATH BENCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12620564
• Report Number: 2438477-2021-00054
• Device Sequence Number: 16494378
• Product Code: ILS
• UDI-Device Identifier: 00822383246253
• UDI-Public: 822383246253
• 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): 10/12/2021
• Report Date (Section F): 10/12/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RTL12203KDR
• Was the Report Sent to FDA?: Yes
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/12/2021