MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH BENCH

Model Number	RTL12505
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a shower chair.The end-user discarded the chair.There are no pictures of the device.(b)(4) will be unable to evaluate the device.The device was purchased 3 months before it broke.It required assembly.It was adjustable for height and had grips for the floor.End-user claimed that the shower chair broke in half from side to side and shattered.The broken plastic injured his hip.The end-user went to his therapist after the incident.End-user is paralyzed on his left side sde due to a stroke.

• Brand Name: DRIVE
• Common Device Name: BATH BENCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8471388
• Report Number: 2438477-2019-00016
• Device Sequence Number: 13899109
• Product Code: ILS
• UDI-Device Identifier: 00822383247151
• UDI-Public: 822383247151
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/01/2019
• Report Date (Section F): 04/01/2019

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?: 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: 01/23/2019
• Device Age: 3 MO
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2019
• 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: Required Intervention
• Patient Weight: 107
• Date Report Sent to FDA: 04/01/2019