MAUDE Adverse Event Report: KOBAYASHI CONSUMER PRODUCTS LLC. WELL AT WALGREENS; HEAT THERAPY PATCHES FOR BACK & LARGE AREAS

Model Number US-WAL522672

Device Problem Device Issue (2379)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 08/11/2016

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 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.The consumer's not adhering to the instructions/warnings on the package resulted in misuse of the product.

Event Description

Burn blisters to 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, applied the (b)(6) heat therapy patch to her lower back for back pain.She wore the patch for approximately 3 1/2 hours.During the 3 1/2 hours she felt no pain or discomfort.Then she reported feeling a burning sensation and discomfort in the area of the patch.She reported that she immediately removed the patch and assessed her back.She stated her back was very hot to the touch and she could feel open blisters from the burn and from where the adhesive had ripped off some of her skin.She stated that she has been to the doctor where they measured, documented, treated and bandaged the area.She states that she did not periodically check her skin and was driving while using the product.The actual device that supposedly caused the injury was discarded by the patient and is not available for testing.The patient did not return unused product from the same retail package for testing and evaluation.The instructions/warnings panel on the product states "do not place extra pressure or tight clothing over this product." the patient using the product on her lower back while driving would exert pressure upon the heat patch and the patient did not frequently check her skin for burns or blisters, as the product instructs on the back panel.Therefore, the instructions/warnings on the product were not followed resulting in accidental or intentional misuse of the product.The manufacturer reviewed batch test records and retained samples 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: WELL AT WALGREENS
• Type of Device: HEAT THERAPY PATCHES FOR BACK & LARGE AREAS
• 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: 5946969
• MDR Text Key: 54579655
• Report Number: 1054358-2016-10003
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00311917099675
• UDI-Public: 311917099675
• 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: 09/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2018
• Device Model Number: US-WAL522672
• Device Catalogue Number: N/A
• Device Lot Number: 160127 6E12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2016
• Initial Date FDA Received: 09/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2016
• 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: 36 YR
• Patient Weight: 64