MAUDE Adverse Event Report: UNITED EXCHANGE CORP. CORALITE COOLING HEADACHE PADS ; PACK, HOT OR COLD, DISPOSABLE

Lot Number	K180683
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Bought an over the counter medication for migraine on (b)(6) 2019.Coralite headache pads caused a severe discoloration to my forehead.Contacted manufacturer (united exchange corporation) and they sent documentation for me to complete.Completed documentation and followed up with several emails and calls.As of this date, the company has not responded to my calls and emails.In addition, i have been left disfigured due to this product.Doctors have prescribed a couple of different medications, but the large patch across my forehead still remains.It is in the shape of the headache pad.Consumers must be made aware.How was it used: transdermal, (b)(6) 2019 - (b)(6) 2019.

• Brand Name: CORALITE COOLING HEADACHE PADS
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): UNITED EXCHANGE CORP.
• MDR Report Key: 9286408
• Report Number: MW5090915
• Device Sequence Number: 16404168
• Product Code: IMD
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/03/2019

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
• Operator of Device: No Information
• Device Expiration Date: 08/31/2021
• Device Lot Number: K180683
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/05/2019
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 85