MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number 795B

Device Problem Material Integrity Problem (2978)

Patient Problem Head Injury (1879)

Event Date 01/07/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator by an end user's daughter, who stated that her mother was using the walker when "the front fork broke and she fell, crashing into [a] vanity," and causing her to "hit her head." she reportedly received medical attention at the scene from paramedics.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• MDR Report Key: 16273307
• MDR Text Key: 308491132
• Report Number: 2438477-2023-00003
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383213484
• UDI-Public: 00822383213484
• 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: 01/30/2023

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: 795B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2023
• Distributor Facility Aware Date: 01/09/2023
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/31/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 92 YR
• Patient Sex: Female
• Patient Weight: 82 KG