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BREG POLAR CARE GLACIERRecalls & reported problems

Breg, Inc. · 1 Ice Water Container, 1 6 VDC output and 120 VAC 60 Hz input transformer · Class 2

Data updated Oct 18, 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 00672736021699), received between Jun 27, 2019 and Jun 27, 2019 — classified as 1 injury.

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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Burn(s)1
  • Deformity/ Disfigurement1
  • Disability1
  • Injury1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 27, 2019Adverse Event Without Identified Device or Use Problem

    ON FEBRUARY 2, 2023, THE DEVICE HISTORY RECORD FOR LOT NUMBER 262119126 WAS REVIEWED AFTER BREG WAS MADE AWARE OF THE LOT NUMBER ASSOCIATED WITH MDR: 2028253-2019-00002.

    Patient problems: Burn(s); Deformity/ Disfigurement; Disability; Injury

    MAUDE report 8741820 ↗

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Sources and updates

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