MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	R726GR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	01/16/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
(b)(6) healthcare was notified of an incident involving a rollator on (b)(6) 2021, but did not receive specific information regarding the injury until on (b)(6) 2022.The end user was reportedly sitting on the unit when the backrest broke, causing him to fall and fracture a rib.Drive is currently investigating the incident, including attempting to inspect the product, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 14105269
• Report Number: 2438477-2022-00021
• Device Sequence Number: 14653970
• Product Code: ITJ
• UDI-Device Identifier: 00822383233215
• UDI-Public: 822383233215
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/13/2022
• Report Date (Section F): 04/13/2022

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: R726GR
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/13/2022
• 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; Required Intervention
• Patient Sex: Male
• Date Report Sent to FDA: 04/13/2022