MAUDE Adverse Event Report: R&R INDUSTRIAL DRIVE; BATH SAFETY

Model Number	RTL12505
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	09/03/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a bath chair.The device was discarded by the end-user.She provided photos.The end-user was showering.She was about to get up when the front right leg cracked causing her to fall forward onto the faucet.She did not seek medical attention.At the time of the incident her ankle had been diagnosed with a sprain.After the incident she was diagnosed with a broken fibula.She is not sure if the fibula was broken before or during the incident.

• Brand Name: DRIVE
• Common Device Name: BATH SAFETY
• Manufacturer (Section D): R&R INDUSTRIAL; #111 dabutou,; songyuan village; guan lan, shanzhen guangdong 51811 0; CH 518110
• MDR Report Key: 7942657
• Report Number: 2438477-2018-00051
• Device Sequence Number: 1665086
• Product Code: ILS
• UDI-Device Identifier: 00822383247151
• UDI-Public: 822383247151
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/05/2018
• Report Date (Section F): 10/08/2018

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: 09/25/2018
• Device Age: 11 MO
• Event Location: Home
• Date Report to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2018
• 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: Required Intervention
• Patient Age: 59 YR
• Patient Weight: 113
• Date Report Sent to FDA: 10/08/2018