MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH BENCH

Model Number	RTL12031KDR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Fall (1848)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss is the initial importer of the device which is a bath bench.The device has not yet been returned for evaluation.In an overabundance of caution we are filing this report since the end user hit theri head.We will amend the report if any additional data is received.The pin rusted on the chair causing the seat to collapse while in use.Enduser fell and hit his head and bruised his back.He did not seek medical attention.

• Brand Name: DRIVE
• Common Device Name: BATH BENCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9955424
• Report Number: 2438477-2020-00022
• Device Sequence Number: 2814635
• Product Code: ILS
• UDI-Device Identifier: 50822383532887
• UDI-Public: 50822383532887
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2020
• Report Date (Section F): 04/13/2020

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: RTL12031KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/13/2020
• Device Age: 4 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 161
• Date Report Sent to FDA: 04/13/2020