MAUDE Adverse Event Report: UNKNOWN DRIVE; TOILET SUPPORT

Model Number	RTL12087
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hip Fracture (2349)
Date of Event	02/03/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a bath safety device toilet support.There are no pictures of the device.We are not expecting return of device.Consumer is requesting compensation.The unit was received august 2018.The handle broke on the left side and caused her to fall.Fire department called to take her to hospital where she was diagnosed with fractured hip and pelvis.Opted out of hip replacement and had hip repaired.Hospitalized for all of (b)(6).Rehab afterwards.Occupational and physical therapists assisted her every day once she was home in (b)(6).

• Brand Name: DRIVE
• Common Device Name: TOILET SUPPORT
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8829133
• Report Number: 2438477-2019-00045
• Device Sequence Number: 2823819
• Product Code: ILS
• UDI-Device Identifier: 00822383252841
• UDI-Public: 822383252841
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/25/2019
• Report Date (Section F): 07/25/2019

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: RTL12087
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/26/2019
• Device Age: 1 YR
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2019
• 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: Hospitalization
• Patient Age: 81 YR
• Patient Weight: 91
• Date Report Sent to FDA: 07/25/2019