MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number R726

Device Problem Unintended Movement (3026)

Patient Problems Bone Fracture(s) (1870); Joint Dislocation (2374)

Event Date 01/21/2020

Event Type  Injury  

Event Description

(b)(4) is the initial importer of the device which is a rollator.The device has not been returned for evaluation.We are filing this report in an overabundance of caution.We will submit a follow up when new information becomes available.The device moved unexpectedly when the end-user grabbed the handles.She fell forward and sustained multiple injuries.She was diagnosed with a left arm fracture in six places, a dislocated left shoulder, and left radial nerve palsy.She underwent surgery as a result.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 11670939
• MDR Text Key: 245557865
• Report Number: 2438477-2021-00011
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383233222
• UDI-Public: 822383233222
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/15/2021

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: R726
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/15/2021
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability