Bair Hugger™ 77500Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00608223775004), received between Feb 17, 2023 and May 8, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Human-Device Interface Problem” (2 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2023Use of Device Problem; Use of Device Problem

  A FEMALE ALLEGEDLY UNDERWENT SURGERY ON (B)(6)2023 AT THE (B)(6) CENTER AND EXPERIENCED AN INJURY NOTED AS A LEFT WRIST 1ST DEGREE BURN, BLISTER, REDNESS WITH SEVERE PAIN THAT REPORTEDLY HEALED AFTER APPROXIMATELY ONE MONTH WITH THE USE OF THE 3M¿ BAIR HUGGER¿ WARMING UNIT. IN PRE-OP, THE NURSE PLACED THE 3M¿ BAIR HUGGER¿ WARMING UNIT ON THE LEFT SIDE OF THE BED. POSTOPERATIVE, THE PATIENT FELT A BURNING SENSATION AT HER LEFT ARM WHICH SHE SHOWED TO THE NURSE WHO REPORTEDLY STATED, "MIGHT HAVE JUST LEAN OVER HER ARM DURING THE SURGERY" AND APPLIED A COLD PACK ON THE PATIENT'S LEFT ARM. THE PATIENT WENT HOME, REMOVED THE COLD PACK, AND OBSERVED BLISTERS. THE PATIENT NOTED SHE THOUGHT THE COLD PACK CAUSED MORE BLISTERING WHICH REPORTEDLY DID NOT LOOK GOOD, AND PRESENTED TO URGENT CARE. THE PHYSICIAN DIAGNOSED THE INJURY AS A BURN AND PRESCRIBED A BURNING CREAM THAT REPORTEDLY DID NOT HELP. THE PATIENT'S CURRENT STATUS NOTED THE BURN IS DRY, AND THE PATIENT IS APPLYING SCAR CREAM TO LIGHTEN UP THE DARK SCAR.

  Patient problems: Blister; Burn(s); Erythema; Pain; Scar Tissue

  MAUDE report 16887077 ↗
• MalfunctionApr 18, 2023Excessive Heating; Excessive Heating

  REPORT RECEIVED FROM THE FDA VIA MEDWATCH FORM (B)(4). A HOSPITAL REPRESENTATIVE REPORTED THE 3M¿ BAIR HUGGER¿ WARMING UNIT ALLEGEDLY OVERHEATED AND REMAINED OVERHEATED AFTER ALL THE SETTINGS WERE TRIED. NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16761734 ↗
• InjuryApr 7, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A PATIENT ALLEGEDLY EXPERIENCED 3RD DEGREE BURNS TO RIGHT THIGH/LEG AND PERMANENT DAMAGE WITH THE USE OF THE 3M¿ BAIR HUGGER¿ WARMING UNIT (MODEL NOT SPECIFIED). THE PATIENT SUBSEQUENTLY UNDERWENT SURGICAL EXCISIONAL DEBRIDEMENT AND SPLIT THICKNESS AUTOGRAFTING FOR WOUND CLOSURE ON OR ABOUT (B)(6) 2022.

  Patient problems: Burn(s)

  MAUDE report 16702435 ↗
• InjuryFeb 17, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A PATIENT ALLEGEDLY EXPERIENCED A BURN WITH THE USE OF 3M¿ BAIR HUGGER¿ WARMING UNIT, MODEL 775. NO MEDICAL INTERVENTIONS WERE REPORTED.

  Patient problems: Burn(s)

  MAUDE report 16397778 ↗