MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	RTL12505
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a bath bench.We are filing this report in an over-abundance of caution due to an mdr regression analysis.The device was returned an evaluated.The end-user was exiting the device when the front leg detached.He fell and hit his head on the faucet.He was taken to the hospital and given x-rays and a cat scan.The unit was evaluated by a quality engineer.One of the inner parts of the leg detached from the outer plastic frame.The unit was missing one of its handles.The leg was set on the lowest setting and the indicator was barely visible.There were no cracks or breaks noticed on the unit.The inner and outer connection was attached by glue and had detached.Possible root cause was that the user over torqued the leg causing the glue to break.Historical data of complaints of the same nature was reviewed and none were found for this issue.This shows no trend.This is considered an isolated incident with root cause cannot be determined.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10820524
• Report Number: 2438477-2018-00085
• Device Sequence Number: 13734851
• Product Code: ILS
• UDI-Device Identifier: 00822383972114
• UDI-Public: 822383972114
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/10/2020
• Report Date (Section F): 11/10/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: RTL12505
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/02/2018
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2020
• 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
• Patient Weight: 109
• Date Report Sent to FDA: 11/10/2020