MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number	10215
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Insufficient Information (4580)
Date of Event	07/24/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) healthcare is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We will file a follow-up when additional information is available.Drive became aware of the incident through a legal notice.We are filing this report in an over abundance of caution.End-user sustained injuries from a fall from the rollator.No other specifics are known.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11874301
• Report Number: 2438477-2021-00018
• Device Sequence Number: 3328816
• Product Code: ITJ
• UDI-Device Identifier: 00822383100647
• UDI-Public: 822383100647
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2021
• Report Date (Section F): 05/24/2021

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: 10215
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/05/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2021
• 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: 05/24/2021