BEKOOOL MIGRAINE COOLING GEL SHEETS

Report

• Report Number: MW5154411
• Event Type: Injury
• Date Received: April 26, 2024
• Date of Event: April 12, 2024
• Report Date: April 24, 2024
• Manufacturer: KOBAYASHI HEALTHCARE INTERNATIONAL/KOBAYASHI CONSUMER PRODUCTS, LLC D/B/A HEATMAX, INC.
• Product Code: IMD
• Adverse Event: Yes
• Report Source: Voluntary report
• Reporter Location: CA, US
• Reporter Occupation: PATIENT
• Health Professional: *

Narratives

Description of Event or Problem · 0

I HAD AN ALLERGIC REACTION WHILE USING A BEKOOOL MIGRAINE COOLING GEL SHEET (HTTPS://BEKOOOL.COM/PRODUCTS/#BKMIGRANE) FOR PAIN RELIEF DURING A MIGRAINE. THE PRODUCT IS REPEATEDLY ADVERTISED AS "NON-MEDICATED," BUT IN FACT IT CONTAINS MENTHOL AS AN ACTIVE INGREDIENT, WHICH IS NOT MENTIONED ANYWHERE ON ITS PACKAGING. IT IS MARKETED AS A PAIN RELIEF PRODUCT, IS MEANT TO BE STUCK TO YOUR SKIN, AND GIVES NO WARNING THAT IT CONTAINS MENTHOL. I WOULD COMPARE IT TO BENGAY OR ICY HOT NOT LISTING THEIR INGREDIENTS ON THEIR PACKAGING. I KNEW I WAS ALLERGIC TO MENTHOL AND WOULD NOT HAVE USED THIS PRODUCT HAD I KNOWN IT CONTAINED IT. WHEN I WAS ALREADY SUFFERING A MIGRAINE, IT CAUSED A PAINFUL BURNING SENSATION ON MY FOREHEAD WHICH WAS VERY DIFFICULT TO STOP, AS MENTHOL DOESN'T EASILY WASH OUT OF SKIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
172758	BEKOOOL MIGRAINE COOLING GEL SHEETS	PACK, HOT OR COLD, DISPOSABLE	IMD	KOBAYASHI HEALTHCARE INTERNATIONAL/KOBAYASHI CONSUMER PRODUCTS, LLC D/B/A HEATMAX, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR	Female	Other

Terms

Patient problem · 2

• Burning Sensation
• Hypersensitivity/Allergic reaction

Type of report · 1

• Initial submission