MAUDE Adverse Event Report: DRIVE; ROLLATOR

Model Number 795RG

Device Problem Fracture (1260)

Patient Problems Fall (1848); Pain (1994); Easy Bruising (4558)

Event Date 02/12/2022

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident that occurred on (b)(6) 2021 involving a rollator/transport chair.The end user reported that she was being transported in the device when the right wheel jammed and fell off, causing her to slide off of the device and land on her knees.The end user reported pain and bruising in both knees, as well as a pulled muscle in her right side as a result of attempting to hold onto the device to avoid falling.The end user also reported that she did not go to the hospital due to covid.Devilbiss is currently investigating the incident, including attempting to retrieve the product to inspect it.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• MDR Report Key: 13698443
• MDR Text Key: 291395908
• Report Number: 2438477-2022-00018
• Device Sequence Number: 1
• Product Code: ITJ
• UDI-Device Identifier: 00822383000855
• UDI-Public: 822383000855
• 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: 03/07/2022,03/11/2022

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: 795RG
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2022
• Distributor Facility Aware Date: 02/14/2022
• Device Age: 3 YR
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 95 KG