MAUDE Adverse Event Report: KENSTONE METAL BARIATRIC ROLLATOR 9153651476; WALKER, MECHANICAL

Model Number 66550

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been reported by a dealer that one wheel on a 66550 rollator is warped out of the box.

• Brand Name: BARIATRIC ROLLATOR 9153651476
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): KENSTONE METAL; kunshan ; CH
• MDR Report Key: 4366316
• MDR Text Key: 15122490
• Report Number: 1531186-2014-06906
• 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: Distributor
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/26/2014,11/17/2014

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: 66550
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/26/2014
• Distributor Facility Aware Date: 11/17/2014
• Date Report to Manufacturer: 12/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other