MAUDE Adverse Event Report: JUNCHENG MECHANICAL WALKER, ROLLATOR; 890.3825

Model Number 6240-5F

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

(b)(6) states the bolts in the right side that go into the mechanism that goes from the front to the rear of the frame are missing, the patient noticed once he had it home and it was replaced right away.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): JUNCHENG; zhongshan ; CH
• MDR Report Key: 3746730
• MDR Text Key: 4414456
• Report Number: 1531186-2014-01314
• 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: Manufacturer
• Source Type: Invalid Data
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 04/11/2014,03/13/2014

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: 6240-5F
• 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: 04/11/2014
• Distributor Facility Aware Date: 03/13/2014
• Event Location: Home
• Date Report to Manufacturer: 04/11/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other