MAUDE Adverse Event Report: R&R INDUSTRIAL LTD DRIVE; BATH CHAIR

Model Number	RTL12505
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	07/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a bath seat.Notice of the incident was tendered by legal entity.We have are awaiting access to the product for evaluation.The end-user was sitting on the device while bathing when it reportedly broke.She landed on her amputation.A fracture was diagnosed in the nub requiring surgical intervention.

• Brand Name: DRIVE
• Common Device Name: BATH CHAIR
• Manufacturer (Section D): R&R INDUSTRIAL LTD; #111 dabutou,; songyuan village; guan lan, shenzhen guangdong 51811 0; CH 518110
• MDR Report Key: 10021804
• Report Number: 2438477-2020-00025
• Device Sequence Number: 16847348
• Product Code: ILS
• UDI-Device Identifier: 00822383247151
• UDI-Public: 822383247151
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2020
• Report Date (Section F): 05/04/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTL12505
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/30/2020
• Device Age: 6 MO
• Date Report to Manufacturer: 05/04/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2020
• 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: Hospitalization
• Date Report Sent to FDA: 05/04/2020