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

Model Number 65650

Device Problems Bent (1059); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2014

Event Type  No Answer Provided  

Event Description

Dealer states the left front leg bent inward 3 inches above the fork assembly and cracked.Son of the enduser states he witnessed it bending after a few minutes of the mother sitting on the rollator.Dealer states end user weighs (b)(6).

• 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: 4245390
• MDR Text Key: 5109546
• Report Number: 1531186-2014-05548
• 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: 11/12/2014,10/24/2014

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: 11/12/2014
• Distributor Facility Aware Date: 10/24/2014
• Date Report to Manufacturer: 11/12/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 129