MAUDE Adverse Event Report: MEDTEC, INC. (CIVCO) TYPE-S THERMOPLASTIC; ACCELERATOR, LINEAR, MEDICAL

Model Number MTAPSD2.4

Device Problem Sticking (1597)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/29/2017

Event Type  malfunction  

Event Description

Thermoplastic mask adhered to acrylic teeth when bite block made for patient's head and neck cancer treatment.When mask removal attempted, found the bite block had adhered to front teeth, which we then found out were acrylic.Dentist was able to remove the bite block.No sure if part of warning label.

Event Description

Bite block had been made from low temperature thermoplastic pellets, for patient's head and neck cancer treatment.The pellets had been put hot water and the mixture then inserted into the mouth to make the bite block.When the thermoplastic mask was taken off, found that the bite block had adhered to front teeth, which we then found out were acrylic.Dentist was able to successfully remove the bite block.Discovered after the fact that a caution statement was on the pellet jar, but the font is very small, not bolded, and not in a color that stands out.

Manufacturer Narrative

The following elements have blank data.

Manufacturer Narrative

The following elements have blank data.

Event Description

Thermoplastic mask adhered to bite block made for patient's head and neck cancer treatment.When mask removal attempted, found the bite block had adhered to front teeth, which we then found out were acrylic.Dentist was able to remove the bite block.No sure if part of warning label.

• Brand Name: TYPE-S THERMOPLASTIC
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): MEDTEC, INC. (CIVCO); 1401 8th st. s.e.; orange city IA 51041
• MDR Report Key: 7479527
• MDR Text Key: 107129214
• Report Number: 7479527
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2017,03/02/2018

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: No Information
• Device Model Number: MTAPSD2.4
• Device Catalogue Number: MTAPSD2.4
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/10/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/10/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/03/2018; 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other