MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	RTL199
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Hip Fracture (2349)
Date of Event	07/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report in an overabundance of caution to be timely.We will submit a follow-up once additional data is received.The device was loaned to a friend who fell and broke her hip.The owner of the device said the device was not the cause of the incident.The user slipped and fell.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 12248541
• Report Number: 2438477-2021-00033
• Device Sequence Number: 2796074
• Product Code: ITJ
• UDI-Device Identifier: 00822383000701
• UDI-Public: 822383000701
• Combination Product (Y/N): N
• 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): 07/29/2021
• Report Date (Section F): 07/29/2021

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: RTL199
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2021
• 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: Other
• Date Report Sent to FDA: 07/29/2021