MAUDE Adverse Event Report: CONSMA JUNIOR ROLLATOR GREEN 9153647181; WALKER, MECHANICAL

Model Number 65350GR

Device Problems Unstable (1667); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been reported that the frame of a 65350gr rollator is lop-sided out of box.

• Brand Name: JUNIOR ROLLATOR GREEN 9153647181
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): CONSMA; no. 158 huicheng rd; huimin ind; jianshan zhejiang ; CH
• MDR Report Key: 4366058
• MDR Text Key: 18931576
• Report Number: 1531186-2014-06874
• 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: 12/24/2014,11/13/2014

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: 65350GR
• 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: 12/24/2014
• Distributor Facility Aware Date: 11/13/2014
• Device Age: 4 MO
• Date Report to Manufacturer: 12/24/2014
• 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