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

Model Number 66550

Device Problems Break (1069); Unstable (1667)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The dealer stated the left brake housing around the brake cable has slit.

• Brand Name: BARIATRIC ROLLATOR 9153651476
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): KENSTONE METAL; kunshan ; CH
• MDR Report Key: 4375426
• MDR Text Key: 18539776
• Report Number: 1531186-2014-07090
• 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: 12/31/2014,12/10/2014

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: 12/31/2014
• Distributor Facility Aware Date: 12/10/2014
• Date Report to Manufacturer: 12/31/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other