ThermaZone 003-99Recalls & reported problems
Innovative Medical Equipment, LLC · ThermaZone Thermal Therapy Device with medical grade power supply · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00854682001356), received between Nov 15, 2017 and Nov 15, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem1
Patient problems
- Partial thickness (Second Degree) Burn1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 15, 2017Use of Device Problem; Use of Device Problem
PATIENT WAS PRESCRIBED THE PRODUCT FOR CHRONIC BACK PAIN AFTER INJURY AND SURGERY, BUT THE INCIDENT OCCURRED WHEN PATIENT DECIDED TO TRY THE PRODUCT ON HER SHOULDER. PATIENT RECEIVED CONTROL UNIT AND MULTIPLE PADS. PATIENT RECEIVED ORAL INSTRUCTIONS FROM HER OCCUPATIONAL THERAPIST ON HOW TO USE THE DEVICE, AND WAS TOLD IT WAS SAFE TO SLEEP IN BECAUSE OF THE AUTO SHUT OFF PROGRAM. PATIENT SAID INSTRUCTIONS FOR USE ACCOMPANIED THE PRODUCT - "BOOKLET AND EACH PAD HAS PAPER IN IT WITH INSTRUCTIONS" - AND THAT SHE REVIEWED BOTH DOCUMENTS. PATIENT USED THE PRODUCT FOR THE FIRST TIME, EXPECTING IT TO SHUT OFF AUTOMATICALLY. PATIENT DOES NOT RECALL THE SEQUENCE OF BUTTONS SHE PRESSED ON THE CONTROL UNIT PRIOR TO APPLICATION OF THE LARGE SHOULDER PAD. WHEN ASKED WHAT PRESET TIMER MODE SHE USED, PATIENT COULD NOT RECALL AND RESPONDED "I CANNOT RECALL BUT ASSUMING THIS IS WHERE I THOUGHT THE MACHINE WAS IN THE CORRECT MODE." PATIENT BELIEVES THE HEAT LEVEL WAS SET TO "8 OR 9". PATIENT FELL ASLEEP FOR APPROXIMATELY 1.5 HOURS. UPON WAKING UP, PATIENT REALIZED THE PRODUCT HAS NOT TURNED OFF AS SHE HAD EXPECTED, AND HER ARM FELT HOT AND SORE. PATIENT TOOK OFF THE SHOULDER PAD, "REVEALING BURNS."
Patient problems: Partial thickness (Second Degree) Burn
MAUDE report 7035117 ↗
Other Pack, Hot Or Cold, Water Circulating devices
- DONJOY 11-1422Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- DONJOY 11-0494Djo, LLC · Pack, hot or cold, water circulating1 recall1 report
- Electri-Cool ll 767Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- Micro-Temp LT 749Gentherm Medical, LLC · Pack, Hot Or Cold, Water Circulating1 recall0 reports
- DONJOY 11-1424Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- DONJOY 11-9099Djo, LLC · Pack, hot or cold, water circulating1 recall0 reports
- T/Pump TP700Stryker Corporation · Pack, hot or cold, water circulating15 reports
- Mul-T-Pad 8002-062-026Stryker Corporation · Pack, hot or cold, water circulating7 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page