MAUDE Adverse Event Report: THE HONEY POT COMPANY LLC HONEY POT; PAD, MENSTRUAL, UNSCENTED

Device Problem Use of Device Problem (1670)

Patient Problems Bacterial Infection (1735); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Itching Sensation (1943); Burning Sensation (2146); Caustic/Chemical Burns (2549); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 02/10/2023

Event Type  Injury  

Event Description

I bought the honey pot pads that were herbal essential infused and i had experience burning sensation after putting on the pad.I stopped using the product.Two days later my vaginal was completely inflamed, irritated, itching and swollen.Had to go the emergency room on two occasions to be told that i had allergic reaction to the pads and it cause my vaginal area to be inflamed and etc.The product gave bacterial infection and chemical burn.

• Brand Name: HONEY POT
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): THE HONEY POT COMPANY LLC; 1115 howell mill rd nw; ste 750; atlanta GA 30318
• MDR Report Key: 16468675
• MDR Text Key: 310686093
• Report Number: MW5115386
• Device Sequence Number: 1
• Product Code: HHD
• 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: 02/27/2023

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?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization; Required Intervention
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American