MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH CHAIR

Model Number	RTL12202KDR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fall (1848); Inadequate Pain Relief (2388)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare is the initial importer of the device which is a shower chair.We have received photos but not the return of the product.The back of the seat broke while in use.The enduser fell in the shower between the chair and the wall.The enduser previously had fusion surgery on his neck and back.The fall exacerbated injuries to neck and back.He has been treated for the pain.

• Brand Name: DRIVE
• Common Device Name: BATH CHAIR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8698290
• Report Number: 2438477-2019-00031
• Device Sequence Number: 2005482
• Product Code: ILS
• UDI-Device Identifier: 00822383247212
• UDI-Public: 822383247212
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 06/13/2019
• Report Date (Section F): 06/13/2019

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: RTL12202KDR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2019
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Weight: 104
• Date Report Sent to FDA: 06/13/2019