MAUDE Adverse Event Report: THE HONEY POT COMPANY LLC 100% ORGANIC COTTON COVER REGULAR PADS - HERBAL INFUSED PADS WITH WINGS; PADS, MENSTRUAL, SCENTED-DEODORIZED

Lot Number	230422-8728
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	11/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The product i would like to have investigated is the honey pot company 100% organic cotton cover regular pads - herbal infused pads with wings.This product caused me uncomfortable itching, burning, and irritation that occurred within the first minute of wearing.I discontinued use after experiencing the sensation and showered for ten minutes until the sensation decreased.The product has a strong flowery odor even though the packaging says "no fragrances," which is a clear lie.I do not have any drug allergies to any of the ingredients and do not have sensitive skin.This product should be investigated for the ingredients that cause the burning sensation, likely the menthol or essential oils, which may not be safe to have prolonged direct contact with vulvar tissue.They also do not have a clear place on their website to file a complaint.

• Brand Name: 100% ORGANIC COTTON COVER REGULAR PADS - HERBAL INFUSED PADS WITH WINGS
• Common Device Name: PADS, MENSTRUAL, SCENTED-DEODORIZED
• Manufacturer (Section D): THE HONEY POT COMPANY LLC; 1115 howell mill rd nw; suite 750; atlanta GA 30318
• MDR Report Key: 18204866
• Report Number: MW5148451
• Device Sequence Number: 6592853
• Product Code: NRC
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/19/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: 230422-8728
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/22/2023
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRENATAL VITAMIN
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White