MAUDE Adverse Event Report: UNKNOWN ECONOMY ROLLATOR W/HAND BRAKE W/CURVE BKRST 9153644547; WALKER, MECHANICAL

Model Number 65650

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported by user that this is the 2nd time that the seat for the 65650 rollator needs to be replaced.User is using it like a wheelchair at times.Causing many cracks on the seat.And pinching his pants.Lives in a senior living facility.Uses indoors and outdoors.Been using for about 1 year.

• Brand Name: ECONOMY ROLLATOR W/HAND BRAKE W/CURVE BKRST 9153644547
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4518459
• MDR Text Key: 5440008
• Report Number: 1531186-2015-00988
• 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: Patient
• Type of Report: Initial
• Report Date: 02/13/2015,02/09/2015

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: 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: 02/13/2015
• Distributor Facility Aware Date: 02/09/2015
• Date Report to Manufacturer: 02/13/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other