MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number RTL10261RD

Device Problem Break (1069)

Patient Problems Fall (1848); Pain (1994)

Event Date 10/27/2021

Event Type  Injury  

Event 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
• Type of Device: ROLLATOR
• MDR Report Key: 15445967
• MDR Text Key: 300140361
• Report Number: 2438477-2022-00091
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383262772
• UDI-Public: 00822383262772
• 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: 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
• Date Report Sent to FDA: 09/19/2022
• Distributor Facility Aware Date: 10/27/2021
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2022
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 118 KG