Hot Dog Underbody Warming Mattress, 127 cm (50in) U102Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00855913001527), received between Apr 19, 2024 and Apr 21, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 21, 2026Use of Device Problem

  AS DESCRIBED BY THE REPORTER THAT NOTIFIED THE MANUFACTURER: ADULT PATIENT UNDERWENT A LONG COSMETIC SURGERY PROCEDURE "LIPOSUCTION (PRONE) - 48 MINS, LIPOSUCTION (SUPINE) - 107 MINS, BREAST REDUCTION (SUPINE) - 202 MINS, ABDOMINOPLASTY (SUPINE/BEACH CHAIR) - 139 MINS; NO SKIN INJURY NOTED AFTER LIPOSUCTION WAS COMPLETED IN THE PRONE POSITIONING. SKIN INJURY NOTED IN PACU BY [NURSE], CONTACTED MD ABOUT SKIN OCCURRENCE. SKIN INJURY WAS NOT NOTED BY OR STAFF DURING SURGERY, AFTER DRAPES REMOVED OR DURING TRANSFER TO STRETCHER BED." THE INJURY WAS DESCRIBED AS "LEFT MEDIAL BUTTOCK - SKIN INJURY" AND "RIGHT MEDIAL BUTTOCK - SMALL SKIN INJURY." THE INJURY WAS BETWEEN 1-10 SQ INCHES (IN TOTAL) AND DESCRIBED AS 2ND DEGREE. IT WAS LINEAR IN SHAPE AND CROSSED INTERGLUTEAL CLEFT. THE PATIENT WAS TREATED POST OP WITH CARBOXYL GEL , ALASTIN NECTAR, MEDICAL GRADE HONEY AND WAS ALSO PRESCRIBED HYPERBARIC TREATMENT. PER INVESTIGATION, THE ROOT CAUSE WAS DETERMINED TO BE A COMBINATION OF A FEW FACTORS 1.THE REPEATED MOVEMENT/REPOSITIONING THROUGHOUT THE PROCEDURE, PARTICULARLY FROM SUPINE TO BEACH CHAIR, LIKELY CAUSED SOME SKIN SHEER ON THE BUTTOCKS AS THE BODY SHIFTED AND MOVED. 2. MACERATION AND

  Patient problems: Partial thickness (Second Degree) Burn; Skin Maceration; Skin Tears

  MAUDE report 24944666 ↗
• InjuryJan 9, 2026Use of Device Problem

  AS DESCRIBED BY THE REPORTER THAT NOTIFIED THE MANUFACTURER: "CLAVICLE FRACTURE SURGERY WITH PLATE FIXATION, PERFORMED IN THE BEACH-CHAIR POSITION. THE PATIENT INITIALLY COMPLAINED OF PAIN IN THE BUTTOCK. THERE WERE NO PROBLEMS DURING THE SURGERY, BUT AT THE END OF THE PROCEDURE THE PATIENT WAS VISIBLY AND PROFUSELY SWEATING. A BURN WAS OBSERVED ON THE BUTTOCK, IN THE INTERGLUTEAL CLEFT AND ADJACENT TO THE ANUS." THE INJURY WAS REPORTED TO BE "SECOND-DEGREE BURN ON THE BUTTOCK, IN THE AREA BETWEEN THE BUTTOCKS AND ADJACENT TO THE ANUS. MEDICAL TREATMENT AND PROTOCOL FOR SECOND-DEGREE BURNS WERE INITIATED." SPECIFIC DETAILS ABOUT SAID TREATMENT WERE NOT PROVIDED. ACCORDING TO THE REPORTER, THE INJURY DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, NOR DID IT NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. PER AUGUSTINE'S INVESTIGATION: THE WARMING MATTRESS WAS RETURNED FOR EVALUATION AND PASSED ALL SAFETY AND FUNCTIONAL TESTS. IT DID NOT MALFUNCTION AND WAS PERFORMING PER SPECIFICATION. AS LONG AS THE PRODUCTS WERE USED IN ACCORDANCE WITH THE IFU, A THERMAL INJURY IS NOT POSSIBLE. THE PATIENT UNDERWENT CLAVICLE FRACTU

  Patient problems: Caustic/Chemical Burns; Partial thickness (Second Degree) Burn

  MAUDE report 24024130 ↗
• InjuryMar 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS DESCRIBED BY THE REPORTER THAT NOTIFIED AUGUSTINE TEMPERATURE MANAGEMENT: "DURING TOTAL CIRCUMCISION, THE HEATING MATTRESS WAS USED, TEMPERATURE WAS SET AT 36 DEG C. AFTER THE PROCEDURE IN THE RECOVERY ROOM, BUTTOCK TENDERNESS BILATERALLY APPEARED. THE PATIENT WAS IMMEDIATELY CHECKED BY HEALTHCARE PROFESSIONAL AND FIRST-DEGREE BURNS IN THE RANGE OF 10 X 10 CM AND 7 X 5 CM WERE DISCOVERED. THE BURNS THEN [PARTLY] DEVELOPED TO GRADE II B." THE BURNS WERE TREATED "AT HOME WITH THE PATIENT ATTENDING OUTPATIENT FOLLOW-UPS AT ON KLADNO - PEDIATRIC SURGERY DEPARTMENT." ACCORDING TO THE LATEST STATEMENT, "THE BURNS HAVE HEALED WITHOUT PERMANENT CONSEQUENCES - NO SCARS." PER AUGUSTINE'S INVESTIGATION: THE PROCEDURE WAS 30 MINUTES. THE TEMPERATURE SETTING ON THE WARMING MATTRESS WAS 36 DEG C AND THERE WAS NO MALFUNCTION. ALL DEVICES TESTED PER SPECIFICATION. BASED ON ALL OF THE INFORMATION PROVIDED, A THERMAL INJURY IS NOT POSSIBLE. ALTHOUGH THE REPORTER DESCRIBES THIS AS A BURN, THIS IS NOT A THERMAL INJURY. IT WAS REPORTED THAT "AN ALCOHOL-BASED DISINFECTANT, SOFTASEPT (CATALOG NUMBER: 19343)" WAS USED. AN IMPERMEABLE "PANEP PAD" WAS UNDER THE PATIENT. MARCAINE -- A LOCAL ANESTHETIC WIT

  Patient problems: Caustic/Chemical Burns; Ischemia; Partial thickness (Second Degree) Burn

  MAUDE report 21589209 ↗
• InjuryJan 23, 2025Use of Device Problem; Use of Device Problem

  AS DESCRIBED BY THE REPORTER THAT NOTIFIED AUGUSTINE TEMPERATURE MANAGEMENT'S DISTRIBUTOR IN AUSTRALIA: "HIP REPLACEMENT SURGERY - TIME: 1.5-2 HOURS. PATIENT WAS NOT NOTICED TO HAVE THE BURN AS THEY HAD SPINAL AND GA ONBOARD- RECOVERY STAFF DISCOVERED THE BURN ON HANDOVER OF THE PATIENT." THE INJURY IS DESCRIBED AS: "2ND DEGREE BURN TO THE LEFT HIP AND ABDOMINAL AREA WITH A SIZE OF 1SQ IN TO 10 SQ INCHES.". THE REPORTER SENT IMAGES AND MENTIONED: "PATIENT REQUIRED ADDITIONAL CARE NEEDS- STAY IN ICU, REVIEW FROM BURNS UNIT AND GENERAL SURGEON." NO ADDITIONAL DETAILS ON THE FOLLOW-UP CARE WERE PROVIDED. ACCORDING TO THE REPORTER, THE INJURY "DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE." PER AUGUSTINE'S INVESTIGATION: THE UNDERBODY MATTRESS U102 S# (B)(6) WAS TESTED ACCORDING TO COMPANY PROCEDURES AND WAS FOUND TO PERFORM PER SPECIFICATION AND PASSED ALL SAFETY AND FUNCTIONAL TESTS. VISUAL INSPECTION SHOWS THE MATTRESS WITH A LOT OF FOLDS AND WRINKLES BUT IS OTHERWISE FREE OF ANY DAMAGES OR ABNORMALITIES; THIS DID NOT ADVERSELY AFFECT THE PERFORMANCE OF THE DEVICE. PER THE IMAGES SENT, THE AREAS ON THE PATIENT THAT SHOW SIGNS OF RE

  Patient problems: Caustic/Chemical Burns; Partial thickness (Second Degree) Burn

  MAUDE report 21223255 ↗
• InjuryJan 22, 2025Use of Device Problem; Use of Device Problem

  AS DESCRIBED BY THE REPORTER (AUGUSTINE TEMPERATURE MANAGEMENT'S MARKET AUTHORIZATION HOLDER) IN A REPORT TO PMDA (JAPAN'S REGULATORY AGENCY FOR MEDICAL DEVICES AND PHARMACEUTICALS): "[PATIENT WAS] UNDERGOING SURGERY FOR AN ABDOMINAL AORTIC, THE PATIENT BODY WAS SET IN THE RIGHT HALF LATERAL POSITION. DURING THIS SURGERY, THE HOTDOG MATTRESS ([KC-T1)]U102) AND THE BLANKET ([KC-T1]B105) WERE USED. AFTER THE SURGERY, WHEN THE PATIENT WAS CARED IN AN I.C.U., BLISTERS WERE FOUND. 3 AREAS WERE CONFIRMED WITH BURNS." THE BURNS WERE DESCRIBED AS "LEVEL 3 BURN OUTSIDE OF THE RIGHT LITTLE TOE- BETWEEN EACH TOE BLACKENED; LEVEL 2 BURN ON TOP PART OF THE LATERAL MALLEOLUS OF THE RIGHT ANKLE AND LEVEL 2 BURN ON THE OUTER SIDE OD ILIOTIBIAL OF THE RIGHT LEG" THE REPORTER ALSO WROTE: "THE CAUSE WAS UNRELATED TO THE MEDICAL DEVICE STATUS. NOTHING IRREGULAR WAS FOUND WITH THE MEDICAL DEVICE. THE [HOTDOG] PRODUCTS USED IN THE SURGERY WERE FOUND TO BE IN WORKING ORDER WITHOUT ANY DEFECTS. DURING PRE-USE INSPECTIONS, AND ARE STILL IN USE AT THE HOSPITAL. DURING THE SURGERY, THE FOLLOWING ITEMS WRITTEN IN THE IFU WERE NEGLECTED AND THE DEVICE WAS MIS-USED: 'PROHIBITION/CONTRAINDICATIONS'- DO NOT USE T

  Patient problems: Full thickness (Third Degree) Burn; Ischemia; Partial thickness (Second Degree) Burn

  MAUDE report 21213499 ↗
• InjuryJan 22, 2025Use of Device Problem; Use of Device Problem

  AS DESCRIBED BY THE REPORTER: "PATIENT PROCEDURE LEFT SKIN AND NIPPLE SPARING MASTECTOMY, SENTINEL NODE BIOPSY/ DISSECTION." THE EVENT/ INCIDENT IS DESCRIBED AS "CONTACT BURN R/ HIP- DEEP PARTIAL THICKNESS- LATERAL POSITION APPROX 90 MINS NOTED BURN END OF PROCEDURE." THE REPORTER MENTIONED THE PATIENT NEEDED "RE-ADMISSION FOR DEBRIDEMENT AND GRAFTING". THE REPORTER IDENTIFIED THAT THIS WAS A THERMAL INJURY WITH A SIZE OF 1 SQ IN TO 10 SQ IN (6.5 SQ CM TO 64.5 SQ CM); THE DEGREE OF THE INJURY IS NOT SPECIFIED. THE INCIDENT NOTES PROVIDED BY THE CUSTOMER MENTION THAT THE MACHINE ALARMED FREQUENTLY IN THIS EVENT. ALSO PER THE CUSTOMER, "[THERE] IS POTENTIAL THAT SENSOR [ON THE MATTRESS] OCCLUDED BY SALINE BAG." PER AUGUSTINE'S INVESTIGATION: THE UNDERBODY MATTRESS U102 WAS TESTED ACCORDING TO COMPANY PROCEDURES AND WAS FOUND TO PERFORM PER SPECIFICATION AND PASSED ALL SAFETY AND FUNCTIONAL TESTS. VISUAL INSPECTION OF THE MATTRESS SHOWS THE MATTRESS ITSELF IS FREE OF ANY DAMAGES OR ABNORMALITIES. THERE WAS SOME PHYSICAL DAMAGE TO THE CONNECTING CABLE, BUT IT DID NOT ADVERSELY AFFECT THE PERFORMANCE OF THE DEVICE. THE REPORTER MENTIONED THE PATIENT NEEDED "RE-ADMISSION FOR DEBRIDEMENT

  Patient problems: Partial thickness (Second Degree) Burn; Pressure Sore/Ulcer

  MAUDE report 21213399 ↗
• InjuryJun 14, 2024Use of Device Problem; Use of Device Problem

  AS DESCRIBED BY THE REPORTER: "LIPOSUCTION WITH FAT GRAFTING TO THE BUTTOCKS AND SPIRAL THIGH LIFT. THE PATIENT WAS PRONE FOR A FEW HOURS, ONCE THE PATIENT WAS FLIPPED, WE NOTICED THE BURN ON THE ANTERIOR ASPECT OF RIGHT THIGH." THE BURN IS ALLEGEDLY A MIXED 2ND/3RD DEGREE BURN COVERING APPROXIMATELY 10 SQ INCHES. A CONVERSATION WITH CLINICAL STAFF REVEALED THAT DURING THE PROCEDURE THE DEVICE ALARMED. A VASOCONSTRICTOR, USING TUMESCENT TECHNIQUE, WAS APPLIED TO THE THIGHS PRIOR TO LIPOSUCTION AND SKIN TIGHTENING WHILE THE PATIENT WAS IN SUPINE. THE PATIENT WAS THEN FLIPPED TO PRONE, AND THE TISSUE THAT HAD BEEN OPERATED ON WAS IN DIRECT CONTACT WITH THE WARMING MATTRESS FOR SEVERAL HOURS. PER AUGUSTINE'S INVESTIGATION: THE WARMING MATTRESS WAS TESTED ACCORDING TO COMPANY PROCEDURES AND WAS NOT PERFORMING TO SPECIFICATIONS. IT FAILED TEMPERATURE UNIFORMITY TESTS AND SHOWED SIGNS OF COOL SPOTS AND WARMER SPOTS. THE WARMER SPOTS WERE ISOLATED TO A FEW LOCATIONS ALONG THE EDGE OF THE MATTRESS (IN THE AREA THAT WOULD HAVE CONTACTED THE INJURY) AND MEASURED AT 46C. THE SENSORS WERE CONFIRMED TO BE WORKING PROPERLY. THE MATTRESS WAS PAST ITS LABELED EXPIRATION DATE. VISUAL INSPECTION OF

  Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn

  MAUDE report 19538911 ↗
• InjuryApr 19, 2024Use of Device Problem; Use of Device Problem

  PER THE REPORTER: PROCEDURE: LEFT MASTECTOMY. DURATION: 90 MINUTES APPROXIMATELY. PATIENT WAS TRANSFERRED FROM WARD BED ONTO OPERATING THEATER TABLE AND HOT DOG, AND SO HAD OPERATING THEATER BLUE COTTON SHEET OVERLAYING THE HOT DOG, PLUS THE PATIENT'S WARD BED WHITE BED SHEET AND DRAW SHEET BETWEEN HERSELF AND THE HOT DOT WARMER MATTRESS. A 1 L BAG OF FLUID WAS PLACED UNDERNEATH THE PATIENT'S LEFT SHOULDER OVERLYING WHERE THE HOT DOG SENSOR IS. TEMPERATURE DISPLAYED ON CONSOLE WAS 39. THE DOCTOR FELT THE HOT DOG MATTRESS PRE-OPERATIVELY, BEFORE THE PATIENT WAS TRANSFERRED ONTO IT. THE HOT DOG MATTRESS WAS WARM AS NORMAL. NOT HOT. ON COMPLETION OF SURGERY, THE PATIENT WAS MOVED, AND THE DOCTOR FELT THE HOT DOG THROUGH HIS GLOVE AND IT FELT HOT. PATIENT WAS RED AND LOOKED SUNBURNT IN ALL AREAS MATCHING CONTACT WITH HOT DOG. THE PATIENT WAS TRANSFERRED OFF THE HOT DOG. BLISTERS WERE OBSERVED AND LATER, THESE BLISTERS SLOUGHED AND EXPOSED AN OPEN WOUND ABOUT THE SIZE OF AN ADULT PALM AND REQUIRED DRESSING. FOR THE NEXT FEW DAYS, THERE WAS AN OPEN WOUND, WHICH REQUIRED NURSING ATTENTION. LATER, SMALL BLISTERS DEVELOPED OVER THE RIGHT SHOULDER/ SCAPULA AREA WHICH REMAINED INTACT AND WERE

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 19143725 ↗