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

Lot Number K180683

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091); Anxiety (2328); Depression (2361); Disability (2371); Caustic/Chemical Burns (2549)

Event Date 05/09/2019

Event Type  malfunction  

Event Description

I used a coralite cooling headache pad and got a 1st degree chemical burn from this product.My entire forehead was burned and throughout the next several days the burn broke vessels underneath the skin and leaked in and around my eyelids and surrounding areas, making them swell severely.Today is the 20th of may and i am still dealing with the effects.My dr can't say if the burn will leave scarring.On top of the burn and swelling i've had head pain and eye pain daily from this.On a more personal level, looking like this, and feeling like this, of course affected my self esteem; i missed my only son's graduation from college, and i am and have been being treated for disability with ptsd, anxiety, ocd, depression, etc for several years and this has really thrown any progress i have made or have been working towards, back.I'm of course anxious about my appearance now, and any future effects to my appearance.I worry about anything i might put on my body, like lotions, soaps, etc.My anxieties keep my thoughts constantly worried and fill my thoughts with anticipatory anxiety (i couldn't even see my 2 little granddaughters for fear they would be scared of me and scarred from my appearance).I do know that the company has been given written warnings ((b)(6), (b)(4)).I will not beat around the bush about this.I am looking for monetary compensation for what i have gone through and will continue to go through.I will be sending photos as well.Thank you.(b)(6).I have already been in contact with (b)(6) at the fda as well.Chemical burn/seen by dr.(b)(6).Frequency: twice a day.How was it taken or used? transdermally.

• Brand Name: CORALITE COOLING HEADACHE PADS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): UNITED EXCHANGE CORPORATION
• MDR Report Key: 8655384
• MDR Text Key: 146925067
• Report Number: MW5087005
• Device Sequence Number: 0
• Product Code: IMD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/31/2021
• Device Lot Number: K180683
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 80