MAUDE Adverse Event Report: QFIX ADAPT-IT; ACCELERATOR, LINEAR, MEDICAL

Model Number RT-7003

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 09/29/2017

Event Type  malfunction  

Event Description

Learned that item involved in an incident was from the use of pellets formed into a bite block, that because not used as directed, adhered to a patient's dentition and a dentist had to remove (previously thought a thermoplastic mask had adhered, but that was not correct-fda notified).

• Brand Name: ADAPT-IT
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): QFIX; 440 church road; avondale PA 19311
• MDR Report Key: 7937709
• MDR Text Key: 122820401
• Report Number: 7937709
• Device Sequence Number: 1
• Product Code: IYE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/29/2018,06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: RT-7003
• Device Catalogue Number: RT-7003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2018
• Date Report to Manufacturer: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other