MAUDE Adverse Event Report: KOBAYASHI CONSUMER PRODUCTS LLC. CURA-HEAT HEAT THERAPY PATCH CLOTHING, SMALL 4 X 5; CURA-HEAT CLOTHING SMALL 4 X 5

Model Number 01103V

Device Problem Device Issue (2379)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/05/2017

Event Type  Injury  

Manufacturer Narrative

The consumer's not adhering to the instructions/warnings on the package resulted in misuse of the product.Although the actual device was discarded by the consumer 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, or inspection of retained samples.Batch records and retained samples met the product specifications and the product is within the 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.

Event Description

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 medication for blood pressure, dementia and uses tramadol for preexisting pain management.The daughter/caregiver did not report any further medical history or concomitant medications used in the area of the reported injury.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 not apply directly to skin.Doing so could result in reddening, blisters or burns."; and "do not use while sleeping, with an electric blanket or heating pad, or near a portable heater." the daughter/caregiver stated that she had attached the product directly to her skin (over an existing scar) and then the patient slept with the product attached.The product was misused under the following circumstances: the patient wore the patch directly on her skin, the patient is unable to apply or remove the warmers herself, the patient wore the patches while sleeping, the patient's skin was not periodically checked, and the patch was placed over an existing scar.The manufacturer reviewed retained samples and batch test records and found the product performed within specifications with no evidence of defect or malfunction.Case comment: based on information provided, the event burns 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 HEAT THERAPY PATCH CLOTHING, SMALL 4 X 5
• Type of Device: CURA-HEAT CLOTHING SMALL 4 X 5
• 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 ; 7062211800
• MDR Report Key: 6739753
• MDR Text Key: 80890369
• Report Number: 1054358-2017-10001
• 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: Other
• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 01/01/2020
• Device Model Number: 01103V
• Device Catalogue Number: N/A
• Device Lot Number: 170214 7C09
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/20/2017
• Initial Date FDA Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2017
• 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): Required Intervention
• Patient Age: 77 YR
• Patient Weight: 67