MAUDE Adverse Event Report: DANYANG MAXTHAI MEDICAL EQUIPMENT ECONOMY ROLLATOR W/HAND BRAKE W/CURVE BKRST 9153644547; WALKER, MECHANICAL

Model Number 65650

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2015

Event Type  malfunction  

Event Description

It was reported by provider that the 65650 rollator was removed from the box and the wheel only turns three quarters of the way.Provider states unit has not been with an end user.

• Brand Name: ECONOMY ROLLATOR W/HAND BRAKE W/CURVE BKRST 9153644547
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): DANYANG MAXTHAI MEDICAL EQUIPMENT; danyang ; CH
• MDR Report Key: 4486490
• MDR Text Key: 5562088
• Report Number: 1531186-2015-00783
• 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: 02/04/2015,01/29/2015

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 65650
• 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: 02/04/2015
• Distributor Facility Aware Date: 01/29/2015
• Device Age: 4 MO
• Date Report to Manufacturer: 02/04/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/05/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other