MAUDE Adverse Event Report: DRIVE MEDICAL; ROLLATOR

Device Problem Insufficient Information (3190)

Patient Problem Skull Fracture (2077)

Event Type  Injury  

Event Description

Source of complaint was attorney.(b)(4) is importer and distributor of device.Product model and serial# not available at time of report.End-user was being pushed/pulled along while seated in the rollator at a gas station.The rollator hit a dip in pavement and caused end-user to fall on the ground.End-user sought medical attention and found a fractured skull and other injuries from the incident.No other information available.Initial call made by gas station attorney was seeking information to prove end-user who was misusing the product.Description of the event did indicate possible misuse of product.There is no information indicating any product defect or malfunction.We are also unable to identify the product and the manufacturer.

• Brand Name: DRIVE MEDICAL
• Type of Device: ROLLATOR
• MDR Report Key: 6793134
• MDR Text Key: 82657967
• Report Number: 2438477-2016-00063
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial
• Report Date: 11/18/2016

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: No Information
• Distributor Facility Aware Date: 11/18/2016
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization