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

Model Number 65650

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

It has been reported by a family member of the end user that when a 65650 rollator taken out of the box, the back left wheel was found to be misshaped and touches the fork.

• 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: 4390213
• MDR Text Key: 5303765
• Report Number: 1531186-2015-00062
• 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: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 01/06/2015,12/15/2014

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: 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: 01/06/2015
• Distributor Facility Aware Date: 12/15/2014
• Device Age: 3 MO
• Date Report to Manufacturer: 01/06/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other