CORALITE HEADACHE COOLING PADS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for CORALITE HEADACHE COOLING PADS manufactured by Unknown.

Event Text Entries

[181948199] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5093434
• MDR Report Key: 9775273
• Date Received: 2020-02-28
• Date of Report: 2020-02-27
• Date of Event: 2020-02-27
• Date Added to Maude: 2020-03-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: CORALITE HEADACHE COOLING PADS
• Generic Name: PACK, HOT OR COLD DISPOSABLE
• Product Code: IMD
• Date Received: 2020-02-28
• Device Availability: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNKNOWN

Device Sequence Number: 101

• Product Code: ---
• Date Received: 2020-02-28
• Device Sequence No: 101
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2020-02-28