BREG PC CUBE W/ M/U XL WORecalls & reported problems
Breg, Inc. · 1 Ice Water Container, 1 6 VDC output, 120 VAC 60 Hz input transformer and 1 04790 WO XL MU Polar Pad · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00672736017739), received between Feb 26, 2018 and Jul 5, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 5, 2018Fluid/Blood Leak
THE DEVICE LEAKED WATER ALL OVER THE PATIENT AND THE BED. THE DEVICE BEGAN LEAKING AFTER IT WAS ALREADY IN USE. STAFF DID NOT HAVE ANY DIFFICULTY SETTING UP THE DEVICE (CONNECTING THE TUBING). STAFF INDICATED THE MOISTURE WAS NOT FROM CONDENSATION, IT WAS A LEAK. THIS IS THE THIRD TIME THIS TYPE OF PROBLEM HAS OCCURRED WITHIN THE LAST YEAR. THE LEAK WAS OVER A SURGICAL SITE BUT NO ADDITIONAL INTERVENTION WAS NEEDED FOR THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7663485 ↗MalfunctionFeb 26, 2018Leak/Splash
THE TUBING TO THE PATIENT END OF THE DEVICE LEAKED ALL OVER THE PATIENT'S DRESSING AND BED. MANUFACTURER RESPONSE FOR PACK, HOT OR COLD, WATER CIRCULATING, BREG (PER SITE REPORTER): NONE YET.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7295664 ↗
Other Pack, Hot Or Cold, Water Circulating devices
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- 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.
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