MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-19 for CORALITE COOLING HEADACHE PADS manufactured by Unk.
[142772530]
Coralite cooling headache pads; i used them for years and all of a sudden i developed a chemical burn. Caused instant burning, stinging and redness. Days following it is still bright red and scaley and painful. After doing some research, i found other people having the same outcome, some being permanently scarred 2 months after. Product type: over-the-counter. Did the problem stop after the person reduced the dose or stopped taking or using the product? Yes. Did the problem return if the person started taking or using the product again? Doesn't apply. Quantity: 1 patch(es). Frequency: as needed. How was it taken or used? Transdermally. Date the person first started taking or using the product: (b)(6) 2016, date the person stopped taking or using the product: (b)(6) 2019. Reason for use: migraines.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086039 |
| MDR Report Key | 8536199 |
| Date Received | 2019-04-19 |
| Date of Report | 2019-04-17 |
| Date of Event | 2019-04-12 |
| Date Added to Maude | 2019-04-22 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CORALITE COOLING HEADACHE PADS |
| Generic Name | PACK, HOT OR COLD, REUSABLE |
| Product Code | IME |
| Date Received | 2019-04-19 |
| Lot Number | K180235 |
| Device Expiration Date | 2019-04-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-19 |