MAUDE Adverse Event Report: POPULAR PLASTICS NON REMOVABLE FOOT/LEGREST 9153645345; FOOTREST, WHEELCHAIR

Model Number T93HE

Device Problems Break (1069); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It has been reported by a dealer that he received foot plates that are cracked and broken from a hospital.

• Brand Name: NON REMOVABLE FOOT/LEGREST 9153645345
• Type of Device: FOOTREST, WHEELCHAIR
• Manufacturer (Section D): POPULAR PLASTICS; guangzhou & donggua ; CH
• MDR Report Key: 4366571
• MDR Text Key: 15122493
• Report Number: 1531186-2014-06931
• Device Sequence Number: 1
• Product Code: IMM
• 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: 12/26/2014,11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T93HE
• 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: 12/26/2014
• Distributor Facility Aware Date: 11/18/2014
• Device Age: 10 MO
• Date Report to Manufacturer: 12/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other