MAUDE Adverse Event Report: INVACARE ROLLATOR; WALKER, MECHANICAL

Model Number 66500

Device Problem Unintended System Motion (1430)

Patient Problem Fall (1848)

Event Type  malfunction  

Event Description

The end user states that the brakes will no longer lock into place.The end user states that he knew the brakes were not locking into place, they were only gripping when the handles were being held.He chose to sit in the device anyway, and when he went to stand up, he pushed himself up by the handles, the device rolled away and he fell backward landing on his butt.The end user states he is fine.No further information available.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ROLLATOR
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17536385
• MDR Text Key: 321521653
• Report Number: MW5143273
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2015

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?: No
• Device Model Number: 66500
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1
• Patient Age: 83 YR