MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number R726BK

Device Problems Device Slipped (1584); Device Damaged Prior to Use (2284)

Patient Problem Bone Fracture(s) (1870)

Event Date 07/17/2019

Event Type  Injury  

Event Description

Drive devilbiss healthcare is the initial importer of the device which is a rollator.We have not received the device for evaluation.End-user has had device for a while.She cannot read the serial number on the device.We ascertained the sku through an image we received of the device.The right brake was not working even after it was tightened repeatedly.While in use the rollator slipped away and she fell.She reportedly crushed a certebrae and was assigned bed rest.No intervention was prescribed.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9191160
• MDR Text Key: 162296307
• Report Number: 2438477-2019-00069
• Device Sequence Number: 1
• Product Code: ITJ
• 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: 10/15/2019

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: R726BK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2019
• Distributor Facility Aware Date: 09/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR
• Patient Weight: 42