MAUDE Adverse Event Report: DOLOMITE AB ROLLATOR ADULT RED 9153641186; WALKER, MECHANICAL

Model Number 12076-43-21

Device Problems Difficult To Position (1467); Device Slipped (1584); Device Tipped Over (2589)

Patient Problems Fall (1848); Neck Pain (2433)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

"the user has during the weekend thought that the walker has been slow and fallen backward indoors on saturday, (b)(6).Decided that on monday contact the municipality regarding this.On sunday loosening a wheel on the walker, the patient stood so he could take support against another object and thus preventing a fall.Called his relatives for help.Repaired on site in the patient's home by wheelchair technician from (b)(6).Both forks and wheels have been changed.Neck pain after the fall for information walker is purchased by (b)(6) because the user needs extra high seat.".

Manufacturer Narrative

The futura is the same /similar to a product or products which are, or have been manufactured and/or marketed by invacare in u.S.The alleged incident occured in (b)(6).The ball bearing breakage is caused by overload of the bearing causing the retainer ring to break with the consequence that the balls are fallen out resulting in disassembly of the fork from the frame.The disassembly will occur after lifting the rollator with the consequence of destabilization that may bring the user to fall.Overloading the bearing could be caused by sitting on the rollator and its usage as ¿wheelchair¿.This risk is known and instruction for use and label on top of the seat warns about the risks.

• Brand Name: ROLLATOR ADULT RED 9153641186
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DOLOMITE AB; vaxjovagen 303; dio ; SW
• Manufacturer (Section G): DOLOMITE AB; vaxjovagen 303; dio ; SW
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4783839
• MDR Text Key: 5818461
• Report Number: 9615290-2015-00187
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 12076-43-21
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2015
• Initial Date FDA Received: 05/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other