MAUDE Adverse Event Report: CONSMA RED ADULT ROLLATOR WITH BASKET 9153647190; WALKER, MECHANICAL

Model Number 65851R

Device Problems Device Inoperable (1663); Out-Of-Box Failure (2311)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

It has been reported by a dealer that when they received a 65851r rollator the hardware for the adjustment knobs and instructions were missing.

• Brand Name: RED ADULT ROLLATOR WITH BASKET 9153647190
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): CONSMA; no. 158 huicheng rd; huimin ind; jianshan zhejiang ; CH
• MDR Report Key: 4335792
• MDR Text Key: 5249160
• Report Number: 1531186-2014-06375
• 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: 12/15/2014,10/23/2014

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: 65851R
• 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: 12/15/2014
• Distributor Facility Aware Date: 10/23/2014
• Device Age: 9 MO
• Date Report to Manufacturer: 12/15/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other