MAUDE Adverse Event Report: UNKNOWN FOOTREST W/AUMINUM FOOTPLATE AND HEEL LOOPS 9153650904; FOOTREST, WHEELCHAIR

Model Number T93HC

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Dealer states, the pin broke off when they went to put these footrests on a chair.

• Brand Name: FOOTREST W/AUMINUM FOOTPLATE AND HEEL LOOPS 9153650904
• Type of Device: FOOTREST, WHEELCHAIR
• Manufacturer (Section D): UNKNOWN; OH
• MDR Report Key: 4344416
• MDR Text Key: 18919972
• Report Number: 1531186-2014-06479
• 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: 12/16/2014,11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: T93HC
• 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: 12/16/2014
• Distributor Facility Aware Date: 11/25/2014
• Date Report to Manufacturer: 12/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other