Cura Heat 667560011039Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00667560011039), received between Sep 1, 2016 and Jul 25, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Issue” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2017Device Issue; Device Issue

  SECOND DEGREE BURN/CONTACT DERMATITIS ON RIGHT THIGH/HIP AREA. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. ON (B)(6), 2017, THE DAUGHTER/CAREGIVER OF THIS (B)(6) FEMALE PATIENT, REPORTED THAT SHE PLACED A 1X1 GAUZE PATCH IN THE CENTER OF A CURA-HEAT HEAT THERAPY PATCH CLOTHING SMALL 4X5 PRODUCT AND THEN APPLIED DIRECTLY TO THE SKIN OF HER MOTHER'S RIGHT THIGH/HIP AREA . THE DAUGHTER/CAREGIVER STATED THAT THE MOTHER SLEPT WITH THE PRODUCTS ATTACHED, OVERNIGHT (APPROX. 8 HRS). THE NEXT MORNING, THE DAUGHTER/CAREGIVER REPORTS THE PATIENT COMPLAINED OF DISCOMFORT AND UPON REMOVAL OF THE PATCH, THE DAUGHTER/CAREGIVER NOTED IT APPEARED THAT THE PATIENT HAD BEEN BURNED AND THE SKIN WAS PEELED. PATIENT WAS SEEN BY A DOCTOR AND DIAGNOSED WITH 2ND DEGREE BURNS ASSOCIATED WITH A PAIN PATCH AND GIVEN AN ORAL ANTIBIOTIC AND TWO ANTIBIOTIC TOPICAL OINTMENTS TO PROMOTE HEALING. THE PATIENT IS UNABLE TO REMOVE OR APPLY THE PATCHES HERSELF DUE TO LOSS OF COGNITIVE SKILLS RELATED TO THE ONSET OF DEMENTIA. THE DAUGHTER/CAREGIVER REPORTED THE PATIENT HAS DEMENTIA, A PREVIOUS HIP REPLACEMENT SURGERY THAT LEFT A SCAR WHERE THE PRODUCT WAS APPLIED. THE PATIENT IS ON MEDICA

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6739753 ↗
• InjurySep 29, 2016Device Issue; Device Issue

  BURNS ON THE UPPER, MIDDLE AND LOWER BACK. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. ON (B)(6) 2016, THIS (B)(6) FEMALE PATIENT OF UNSPECIFIED ETHNICITY, REPORTED THAT SHE APPLIED THREE CURA-HEAT THERAPY PATCH CLOTHING SMALL 4X5 PRODUCTS, SIMULTANEOUSLY, DIRECTLY TO THE SKIN OF HER UPPER, MIDDLE AND LOWER BACK, THE PREVIOUS EVENING. THE PATIENT STATED THAT SHE SLEPT WITH THE PRODUCTS ATTACHED FOR APPROXIMATELY TEN HOURS. THE PATIENT REPORTS DISCOVERING BURNS TO THE UPPER, MIDDLE AND LOWER BACK, THE FOLLOWING MORNING. THE PATIENT REPORTED HAVING "DEGENERATIVE DISCS" AND ARTHRITIS IN HER SHOULDERS, THE PATIENT DID NOT REPORT ANY FURTHER MEDICAL HISTORY OR CONCOMITANT MEDICATIONS. THE PATIENT HAS NOT SOUGHT PROFESSIONAL MEDICAL ATTENTION AND ADMITTED TO USING THE PRODUCT IMPROPERLY. THE PATIENT WAS ASKED TO PROVIDED PHOTOS OF THE INJURED AREAS FOR REVIEW. HOWEVER, WHEN CONTACTED ON A FOLLOW UP CALL, THE PATIENT STATED THAT SHE WILL NOT SEND PHOTOS AND REQUESTED THAT SHE NOT BE CONTACTED AGAIN. THE ACTUAL DEVICE THAT SUPPOSEDLY CAUSED THE INJURY WAS DISCARDED BY THE PATIENT AND IS NOT AVAILABLE FOR TESTING. THE WARNINGS PANEL ON THE PRODUCT STATES "DO

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5987447 ↗
• InjurySep 1, 2016Device Issue; Device Issue

  BLISTERS ON THE BACK OF BOTH KNEES. CASE DESCRIPTION: THIS IS A SPONTANEOUS REPORT FROM A CONTACTABLE CONSUMER. ON (B)(6) 2016, THIS (B)(6) MALE PATIENT OF UNSPECIFIED ETHNICITY, APPLIED THE CURA-HEAT HEAT THERAPY PATCHES PRODUCT TO THE BACK OF BOTH KNEES ON TOP OF ACE BANDAGES TO EASE THE PAIN FROM HIS HAMSTRINGS. THE PATIENT WAS ADVISED BY A PHYSICIAN TO USE HEAT OR COLD THERAPY FOR THE HAMSTRING PAIN. OTHER THAN ARTHRITIS, THE PATIENT DID NOT REPORT ANY FURTHER MEDICAL HISTORY OR CONCOMITANT MEDICATIONS. THE PATIENT HAS NOT SOUGHT PROFESSIONAL MEDICAL ATTENTION, HOWEVER HIS WIFE STATED THAT SHE IS A NURSE AND HAS BEEN TREATING THE INJURIES. THE PATIENT PROVIDED PHOTOS OF THE INJURED AREAS FOR REVIEW. THE ACTUAL DEVICE THAT SUPPOSEDLY CAUSED THE INJURY WAS DISCARDED BY THE PATIENT AND IS NOT AVAILABLE FOR TESTING. THE PATIENT DID RETURN UNUSED PRODUCT FROM THE SAME RETAIL PACKAGE FOR TESTING AND EVALUATION. THE WARNINGS PANEL ON THE PRODUCT STATES "DO NOT USE ON BRUISES OR SWELLING, OR IF YOU ARE A DIABETIC"; AND "MONITOR FREQUENTLY IF YOU HAVE SENSITIVE SKIN". THE PATIENT STATED THAT HE HAD INFLAMMATION AROUND THE AFFECTED AREA AND HE DID NOT PERIODICALLY CHECK THE SENSITIVE SKI

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 5920868 ↗