MAUDE Adverse Event Report: MEDTEC, INC. REDIFOAM TWO-PART FOAMING AGENT; ACCELERATOR, LINEAR, MEDICAL

Model Number MTFA41B

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2022

Event Type  malfunction  

Event Description

After construction of the patient's body mold and simulation, therapists noticed redifoam mix was not hardening like it usually does (it dimpled to the touch).After roughly 24 hours, therapists noticed patient's body mold began to shrink and lose its form or shape which could cause misalignment of radiation treatment.A new simulation and body mold had to be created which could have caused a delay in the patient's cancer treatments.

• Brand Name: REDIFOAM TWO-PART FOAMING AGENT
• Type of Device: ACCELERATOR, LINEAR, MEDICAL
• Manufacturer (Section D): MEDTEC, INC.; 1401 8th st. s.e.; orange city IA 51041
• MDR Report Key: 14642416
• MDR Text Key: 293623728
• Report Number: 14642416
• 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: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MTFA41B
• Device Catalogue Number: MTFA41B
• Device Lot Number: M160049
• 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: 06/07/2022
• Date Report to Manufacturer: 06/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1