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

Model Number 65350GR

Device Problem Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Per tbm the backrest attachment on left side is welded incorrectly, so back will not snap in place.

• Brand Name: MECHANICAL WALKER, ROLLATOR
• Type of Device: 890.3825
• Manufacturer (Section D): CONSMA; no. 158 huicheng rd; huimin ind; jianshan zhejiang 3141 12; CH 314112
• MDR Report Key: 4167632
• MDR Text Key: 16782142
• Report Number: 1531186-2014-04880
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• 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: 10/13/2014,09/25/2014

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: 10/13/2014
• Distributor Facility Aware Date: 09/25/2014
• Device Age: 6 MO
• Date Report to Manufacturer: 10/13/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other