MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number R726BL

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Easy Bruising (4558)

Event Date 02/03/2022

Event Type  Injury  

Event Description

(b)(4) was notified of an incident involving a rollator on (b)(6).The end-user fell upon a wooden floor while using the device to traverse to her bedroom.As per the report, the end user landed on her backside bruising her back and wrists.She reported that: "may end up needing some kind of operation." she requested new wheels.Her husband is refusing to return the device for evaluation and has not provided information regarding the injury or the treatment.Drive is currently investigating the incident, including attempting to retrieve the product to inspect it.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• MDR Report Key: 13666289
• MDR Text Key: 286563727
• Report Number: 2438477-2022-00017
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233208
• UDI-Public: 822383233208
• 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: 03/04/2022

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 Operator: Lay User/Patient
• Device Model Number: R726BL
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2022
• Distributor Facility Aware Date: 02/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 57 KG