MAUDE Adverse Event Report: ROLLING WALKER; ROLLATOR

Model Number FGA22200 0000

Device Problem Unstable (1667)

Patient Problem No Code Available (3191)

Event Date 05/17/2016

Event Type  Injury  

Event Description

Customer called to report that both of the front wheels are really wobbly on the rollator.Sometimes the right wheel stops moving altogether, and the customer fell when this happened.The customer did state she did go to the doctor and physical therapy.She did not indicate whether the it was for the fall or for other reasons.

• Brand Name: ROLLING WALKER
• Type of Device: ROLLATOR
• MDR Report Key: 5695300
• MDR Text Key: 46424888
• Report Number: 2182780-2016-00007
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FGA22200 0000
• Device Catalogue Number: A222-00
• 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: 06/02/2016
• Distributor Facility Aware Date: 05/17/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other