RediFoam™ MTFA41BRecalls & reported problems
Medtec, Inc. · Two-part Foaming Agent Part A (21.8oz) and Foaming Agent Part B (24.6oz) · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841439110904), received between Jul 21, 2022 and Jul 21, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Improper Chemical Reaction” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Improper Chemical Reaction1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 21, 2022Improper Chemical Reaction; Improper Chemical Reaction
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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15077839 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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