CORALITE COOLING HEADACHE PADS
Received Jan 6, 2020 · Event occurred Mar 29, 2019
Report MW5092084 · MDR key 9559471
Device
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
52 YR
- Erythema
- Headache
- Swelling
- Burn, Thermal
- Erythema
- Headache
- Swelling
- Burn, Thermal
Narrative
Description of Event or Problem
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).