MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	10289RD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Easy Bruising (4558)
Date of Event	09/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(4) is the initial importer of the device which is a rollator.We have not received the device for evaluation.We will submit a follow-up when additional data is available.While in use the caster broker off of the unit.The user fell and hit her head.She also acquired scrapes on her arms.She did not seek medical attention.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 12573824
• Report Number: 2438477-2021-00051
• Device Sequence Number: 11634955
• Product Code: ITJ
• UDI-Device Identifier: 00822383259338
• UDI-Public: 822383259338
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 10/04/2021
• Report Date (Section F): 10/04/2021

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: 10289RD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/29/2021
• Device Age: 5 MO
• Date Report to Manufacturer: 10/06/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/04/2021