MAUDE Adverse Event Report: KOBAYASHI HEALTHCARE INTERNATIONAL/KOBAYASHI CONSUMER PRODUCTS, LLC D/B/A HEATMAX, INC. BEKOOOL MIGRAINE COOLING GEL SHEETS; PACK, HOT OR COLD, DISPOSABLE

Patient Problems Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146)

Event Date 04/12/2024

Event Type  Injury  

Event Description

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.

• Brand Name: BEKOOOL MIGRAINE COOLING GEL SHEETS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): KOBAYASHI HEALTHCARE INTERNATIONAL/KOBAYASHI CONSUMER PRODUCTS, LLC D/B/A HEATMAX, INC.
• MDR Report Key: 19212050
• MDR Text Key: 341493587
• Report Number: MW5154411
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/26/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White