MAUDE Adverse Event Report: KOBAYASHI CONSUMER PRODUCTS LLC. CURA-HEAT; HEAT THERAPY PATCHES 4"X5"

Model Number 01103VPD

Device Problem Device Issue (2379)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/09/2016

Event Type  Injury  

Manufacturer Narrative

Although the actual device was discarded by the patient and not returned, the manufacturer has reviewed this batch from a manufacturing and technical perspective.No quality issues were identified upon this review of batch records, testing data or inspection of retained samples.Batch records met the product specifications and the product is within expiration date.After a review of the thermal batch records, thermal results all met product release criteria.The review of the records does not provide evidence to support defective product.The consumer's not adhering to the warnings on the package resulted in misuse of the product.

Event Description

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 skin on the back of the knees while wearing the product.Therefore, the warnings on the product was not followed resulting in accidental or intentional misuse of the product.The manufacturer reviewed batch test records and tested the returned unused products and found the product performed within specifications with no evidence of defect or malfunction.Case comment: based on information provided, the event burn blisters as described in this case represents a serious bodily injury potentially requiring medical intervention to prevent further permanent damage or impairment of body structure(s) that can result in deterioration of health and state of well-being of the user.This case meets initial 30-day fda reportability.

• Brand Name: CURA-HEAT
• Type of Device: HEAT THERAPY PATCHES 4"X5"
• Manufacturer (Section D): KOBAYASHI CONSUMER PRODUCTS LLC.; 245 kraft drive; dalton GA 30721
• Manufacturer (Section G): KOBAYASHI AMERICA MANUFACTURING LLC.; 245 kraft drive; dalton GA 30721
• Manufacturer Contact: william tipton ; 245 kraft drive; dalton, GA 30721 ; 7062261800
• MDR Report Key: 5920868
• MDR Text Key: 53691266
• Report Number: 1054358-2016-10002
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00667560011039
• UDI-Public: 667560011039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/15/2018
• Device Model Number: 01103VPD
• Device Catalogue Number: N/A
• Device Lot Number: 151015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 91