MAUDE Adverse Event Report: INVACARE WALKER, MECHANICAL

Model Number 66500

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Per territory business manager (b)(6) all the tires are falling apart on the rollator.Dealer stated hand grips looked like they have been replaced and cannot read lot number.Tbm could not provide any further information.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: WALKER, MECHANICAL
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): INVACARE
• MDR Report Key: 17530503
• MDR Text Key: 321353435
• Report Number: MW5137422
• 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: 03/27/2015

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