MAUDE Adverse Event Report: UNKNOWN DRIVE; ROLLATOR

Model Number 795

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Fall (1848); Injury (2348)

Event Date 11/04/2015

Event Type  Death  

Event Description

(b)(4) is the initial importer of the device.(b)(4) was made aware of the incident by legal notice from attorneys over two years after date of incident.End-user was being pushed in rollator/transport chair combo device along a hallway.The floor of the hallway was pitted and not smooth.The device hit a pothole and the end-user fell forward.She reportedly sustained multiple injuries.The end-user died of secondary complications due to the injuries sustained.

• Brand Name: DRIVE
• Type of Device: ROLLATOR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 7070798
• MDR Text Key: 93330974
• Report Number: 2438477-2017-00088
• 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: Attorney
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Model Number: 795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death