MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-06 for CORALITE COOLING HEADACHE PADS manufactured by Unk.
[174269537]
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).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092084 |
| MDR Report Key | 9559471 |
| Date Received | 2020-01-06 |
| Date of Report | 2020-01-02 |
| Date of Event | 2019-03-29 |
| Date Added to Maude | 2020-01-07 |
| 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 |
| Brand Name | CORALITE COOLING HEADACHE PADS |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2020-01-06 |
| Lot Number | A17CHP02 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Product Code | --- |
| Date Received | 2020-01-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-06 |