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

Device Problem Output Problem (3005)

Patient Problems Erythema (1840); Rash (2033); Reaction (2414); Skin Inflammation (2443); Tissue Breakdown (2681)

Event Date 02/27/2020

Event Type  Injury  

Event Description

Hello my name is (b)(6) i used the cooling headache/ migraine pads a month and a half ago and my skin got red and inflamed very bad, i couldn't even go to work because my forehead was just burning really bad and skin stated cracking and peeling when i went to the doctor he thought it was rosacea because he said that he can't find out what else can it be so they gave me antibiotics that made it worse.I bought this, a face wash and it balanced it a little bit and then yesterday i used it again and i woke up in the morning with the same rash but now it¿s worse.I really don't know what to do anymore and that how i found out that it was the pads.It¿s not ok that there¿s no side effects on the package.Please help me.

• Brand Name: CORALITE HEADACHE COOLING PADS
• Type of Device: PACK, HOT OR COLD DISPOSABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9775273
• MDR Text Key: 181948199
• Report Number: MW5093434
• Device Sequence Number: 1
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 05/01/2022
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 33 YR
• Patient Weight: 75