MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number R726BK

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problem Abrasion (1689)

Event Date 11/07/2021

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a rollator.The end user stated that she was sitting in her rollator, swung her leg around, and the brake assembly cut her leg.She sought medical attention and received ongoing wound care.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: 15053587
• MDR Text Key: 296152085
• Report Number: 2438477-2022-00035
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383240664
• UDI-Public: 822383240664
• 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: 07/19/2022

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?: No
• Device Model Number: R726BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2022
• Distributor Facility Aware Date: 03/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Sex: Female