MAUDE Adverse Event Report: UNKNOWN DRIVE; BATH BENCH

Model Number	RTL12606
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Fall (1848); Limb Fracture (4518)
Date of Event	07/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a shower chair.The device has not been returned for evaluation.A follow-up will be filed when additional information is received.The bath bench broke while in use in the shower.The user fell.She reinjured her femoral head which had already undergone surgery and is currently under treatment.The fracture was so close to the knee that it was damaged as well.Tree is a potential of surgery on the knee.

• Brand Name: DRIVE
• Common Device Name: BATH BENCH
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12316876
• Report Number: 2438477-2021-00035
• Device Sequence Number: 11706970
• Product Code: ILS
• UDI-Device Identifier: 00822383525891
• UDI-Public: 822383525891
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2021
• Report Date (Section F): 08/11/2021

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: RTL12606
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/29/2021
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/12/2021
• 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: 74 YR
• Patient Weight: 113
• Date Report Sent to FDA: 08/11/2021