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U.S. Department of Health and Human Services

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

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CORALITE COOLING HEADACHE PADS; PACK, HOT OR COLD, REUSABLE Back to Search Results
Lot Number A17CHP02
Health Effect - Clinical Codes Erythema (1840); Headache (1880); Swelling (2091); Burn, Thermal (2530)
Date of Event 03/29/2019
Type of Reportable Event Serious Injury
Event or Problem Description
On (b)(6) 2019, i had a migraine headache and picked up and used coralite cooling headache pads from the (b)(6) store.I have used multiple headache pads for migraine headaches in the past.The night of (b)(6) 2019 i used the patch and put it on my forehead as instructed.The next morning my headache had not completely ended, but now my forehead was swollen very badly and was beet red.My eyes were swollen as well as my nose and cheeks.I had the swelling for more than 4 days and could not use cosmetics on my skin as i had a serious burn to my forehead.Over the next 2 weeks the skin on my forehead peeled from the severe burn to my forehead.I had a phone appointment with my doctors office, unfortunately my doctor was on vacation, and the dr i spoke with prescribed cortisone cream for my forehead and ibuprofen for the swelling and pain.Since this occurrence i have not recovered 100%.Coralite cooling headache pads, distributed by (b)(4).Lot# a17chp02, expiration: 11/2020; made in (b)(4).
 
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Brand Name
CORALITE COOLING HEADACHE PADS
Common Device Name
PACK, HOT OR COLD, REUSABLE
MDR Report Key9559471
Report NumberMW5092084
Device Sequence Number19063866
Product Code IME
Combination Product (Y/N)Y
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Patient
Type of Report Initial
Report Date (Section B) 01/02/2020
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 Date11/01/2020
Device Lot NumberA17CHP02
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date01/06/2020
Patient Sequence Number1
Patient Age52 YR
Patient Weight56
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