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 09/09/2016

Event Type  Injury  

Manufacturer Narrative

The consumer's not adhering to the instructions/warnings on the package resulted in misuse of the product.The patient admitted misuse of the product and requested that she not be contacted, again.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, or inspection of retained samples.Batch records and retained samples 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.

Event Description

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 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 patient stated that she had attached three patches directly to her skin and then slept with the products.Therefore, the warnings on the product was not followed, resulting in accidental or intentional misuse of the product.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 ; 7602261800
• MDR Report Key: 5987447
• MDR Text Key: 55998109
• Report Number: 1054358-2016-10004
• 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: Patient
• Type of Report: Initial
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2018
• Device Model Number: 01103V
• Device Catalogue Number: N/A
• Device Lot Number: 150519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• 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: 68 YR
• Patient Weight: 44