MAUDE Adverse Event Report: ROLLATOR WITH FOLD UP AND REMOVABLE BACK SUPPORT AND PADDED SEAT, RED BY DRIVE M

Model Number R726RD

Device Problems Break (1069); Material Deformation (2976)

Patient Problems Fall (1848); Head Injury (1879); Injury (2348)

Event Date 12/03/2017

Event Type  Injury  

Event Description

I have a drive medical rollator with a seat.The company website says the device is made for someone weighing about (b)(6).First a few months ago the seat caved in.I called the supplier (b)(4) but they did not repair/replace the seat.Then on (b)(6) 2017 a metal support broke (almost as if sawed) and i flipped over the device hurting my head, neck, shoulders and back.I called (b)(4) and they initially refused to fix or replace it.They finally agreed to replace it after i told them that i intended to report these defects.(b)(4).

• Brand Name: ROLLATOR WITH FOLD UP AND REMOVABLE BACK SUPPORT AND PADDED SEAT, RED BY DRIVE M
• Type of Device: ROLLATOR
• MDR Report Key: 7101220
• MDR Text Key: 94479413
• Report Number: MW5073859
• 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: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: R726RD
• Device Catalogue Number: R726RD
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Weight: 73