MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	795RG
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Easy Bruising (4558)
Date of Event	02/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident that occurred on (b)(6) 2021 involving a rollator/transport chair.The end user reported that she was being transported in the device when the right wheel jammed and fell off, causing her to slide off of the device and land on her knees.The end user reported pain and bruising in both knees, as well as a pulled muscle in her right side as a result of attempting to hold onto the device to avoid falling.The end user also reported that she did not go to the hospital due to covid.Devilbiss is currently investigating the incident, including attempting to retrieve the product to inspect it.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 13698443
• Report Number: 2438477-2022-00018
• Device Sequence Number: 5957082
• Product Code: ITJ
• UDI-Device Identifier: 00822383000855
• UDI-Public: 822383000855
• Combination Product (Y/N): N
• 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): 03/11/2022
• Report Date (Section F): 03/07/2022

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: 795RG
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/14/2022
• Device Age: 3 YR
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2022
• 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: Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Date Report Sent to FDA: 03/07/2022