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

Model Number 65350GR

Device Problems Unstable (1667); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

The end user wrote to the dealer: "last week i heard a loud crack, and later that morning i was pushing my rollator through a parking lot with a front wheel locked 90 degrees from normal.The caster on the right is normal.The left is the broken caster.I manually loosened it up and if i don't make a sharp turn it's kind of usable." advised dealer the unit is from 2012, order (b)(4), and is no longer under warranty.Po# (b)(4) shows we have replaced the seat repeatedly, so could allege excessive use or excess of weight capacity, but no issues with the seat at this time.

• Brand Name: JUNIOR ROLLATOR GREEN 9153647181
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4444359
• MDR Text Key: 15117054
• Report Number: 1531186-2015-00513
• 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: 01/22/2015,01/14/2015

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: 01/22/2015
• Distributor Facility Aware Date: 01/14/2015
• Date Report to Manufacturer: 01/22/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other