MAUDE Adverse Event Report: MEDTEC LLC, DBA CIVCO RADIOTHERAPY REDIFOAM TWO-PART FOAMING AGENT

Model Number MTFA41B

Device Problem Improper Chemical Reaction (2952)

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

Event Type  malfunction  

Event Description

The user notified the fda via voluntary reporting forms, identified below, stating "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." death or serious injury did not occur and would be likely to occur.Facility mdr numbers: (b)(4) - event date: (b)(6) 2022.(b)(4) - event date: (b)(6) 2022.(b)(4) - event date: (b)(6) 2022.(b)(4) - event date: (b)(6) 2022.(b)(4) - event date: (b)(6) 2022.(b)(4) - event date: (b)(6) 2022.

Manufacturer Narrative

Poor expansion of an incorrect ratio of part a & part b is highly detectable by the user during the forming process as the material is soft and will have further shrunk prior to treatment, thus either causing difficulty of fitting patient or the patient not fitting back into the system.Patient mistreatment is unlikely due to the high detectability of the issue.However, for the redifoam with poor expansion to cause mistreatment the user would have to not detect the softness, due to under-reaction, use no other positioning devices, not perform patient position verification checks, and also be treating with hypo-fractionation.The user is highly likely to detect the redifoam is soft through touch or didn't properly expand prior to treatment as the patient would not fit into the previous formed unit, imaging of the patient would show misalignment and the likelihood of an adverse event occurring would be improbable due to the combination of events required.Therefore, due to the combination of events required, high detection, and low occurrence the risk is considered low and no reporting or field action is necessary.Civco rt is filing a corresponding mdr in response to filing by the user site.

• Brand Name: REDIFOAM TWO-PART FOAMING AGENT
• Type of Device: REDIFOAM
• Manufacturer (Section D): MEDTEC LLC, DBA CIVCO RADIOTHERAPY; 1401 8th street se; orange city IA 51041
• Manufacturer (Section G): MEDTEC LLC, DBA CIVCO RADIOTHERAPY; 1401 8th street se; orange city IA 51041
• Manufacturer Contact: alena newgren ; 1401 8th street se; orange city, IA 51041 ; 3192586650
• MDR Report Key: 15077839
• MDR Text Key: 304721091
• Report Number: 1932738-2022-60001
• Device Sequence Number: 1
• Product Code: IYE
• UDI-Device Identifier: 00841439110904
• UDI-Public: 00841439110904
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial

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: Health Professional
• Device Model Number: MTFA41B
• Device Catalogue Number: MTFA41B
• Device Lot Number: M160049
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1