MAUDE Adverse Event Report: UNKNOWN WALKER, MECHANICAL

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The end user states that the wheel has cracked.The end user states that it is the back right tire.No further information is available.Bariatric rollator, no injury alleged 293912.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): UNKNOWN
• MDR Report Key: 17533851
• MDR Text Key: 321347699
• Report Number: MW5140754
• 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: 03/09/2015

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1