MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number	RTL10261RD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Fall (1848); Pain (1994)
Date of Event	10/27/2021
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 reported that "he sat down on the rollator at his desk and the unit broke causing him to fall, aggravating [his] pre-existing back condition." the end user reported that the incident caused severe pain requiring medication.The end user did not return the product for evaluation.

• Brand Name: DRIVE
• Common Device Name: ROLLATOR
• MDR Report Key: 15445967
• Report Number: 2438477-2022-00091
• Device Sequence Number: 20713398
• Product Code: ITJ
• UDI-Device Identifier: 00822383262772
• UDI-Public: 00822383262772
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/19/2022
• Report Date (Section F): 09/19/2022

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 Model Number: RTL10261RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/27/2021
• Event Location: Home
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2022
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 118 KG
• Date Report Sent to FDA: 09/19/2022