CORALITE COOLING HEADACHE PADS
Received Apr 19, 2019 · Event occurred Apr 12, 2019
Report MW5086039 · MDR key 8536199
Device
Product problems
- Patient-Device Incompatibility
Patient
31 YR
- Erythema
- Burning Sensation
- Caustic/Chemical Burns
- Erythema
- Burning Sensation
- Caustic/Chemical Burns
Narrative
Description of Event or Problem
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.