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

Model Number 65851R

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

End user's husband called stating that the seat is starting to crack.

• Brand Name: RED ADULT ROLLATOR WITH BASKET 9153647190
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4316804
• MDR Text Key: 15328549
• Report Number: 1531186-2014-06161
• 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 Family Member or Friend
• Type of Report: Initial
• Report Date: 12/09/2014,11/17/2014

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: 12/09/2014
• Distributor Facility Aware Date: 11/17/2014
• Date Report to Manufacturer: 12/09/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other