MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number 146-R726RD

Device Problem Fracture (1260)

Patient Problems Fall (1848); Neck Pain (2433)

Event Date 03/12/2020

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.The unit was not returned for evaluation due to covid-19.We received images but no evaluation report from the service provider.We will file a follow up if new information is available.Service provider's reference number is (b)(4).End-user sat on the device and the wheel came off.He fell to the ground and hurt his head, shoulder and mouth.His dentures were damaged requiring dental work.The serial number was rubbed off of the unit from use.Service provider has no additional information.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 10114038
• MDR Text Key: 194812316
• Report Number: 2438477-2020-00032
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00612479223097
• UDI-Public: 612479223097
• 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: 06/03/2020,06/01/2020

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 Operator: Lay User/Patient
• Device Model Number: 146-R726RD
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2020
• Distributor Facility Aware Date: 04/04/2020
• Event Location: Home
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other