MAUDE Adverse Event Report: DRIVE MEDICAL; ROLLATOR

Model Number 10289RD

Device Problem Break (1069)

Patient Problems Laceration(s) (1946); Scar Tissue (2060)

Event Type  Injury  

Event 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
• Type of Device: ROLLATOR
• MDR Report Key: 15807200
• MDR Text Key: 303752225
• Report Number: 2438477-2022-00108
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383259338
• UDI-Public: 00822383259338
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Lay User/Patient
• Device Model Number: 10289RD
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2022
• Distributor Facility Aware Date: 08/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Sex: Female
• Patient Weight: 95 KG