MAUDE Adverse Event Report: DRIVE MEDICAL; ROLLATOR

Model Number	10289RD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Laceration(s) (1946); Scar Tissue (2060)
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an end user, who stated that the unit's "handlebar snapped and caused the patient to fall." the product was returned to drive for evaluation, but the root cause could not be determined upon visual inspection.Drive is coordinating with external materials experts to determine whether it is possible to identify the root cause.Drive will file an update if additional information becomes available.

• Brand Name: DRIVE MEDICAL
• Common Device Name: ROLLATOR
• MDR Report Key: 15807200
• Report Number: 2438477-2022-00108
• Device Sequence Number: 5471686
• Product Code: ITJ
• UDI-Device Identifier: 00822383259338
• UDI-Public: 00822383259338
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/16/2022
• Report Date (Section F): 11/16/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 10289RD
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/22/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2022
• 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
• Patient Sex: Female
• Patient Weight: 95 KG
• Date Report Sent to FDA: 11/16/2022