MAUDE Adverse Event Report: THE HONEY POT COMPANY LLC. HONEY POT HERBAL INFUSED PADS; PAD, MENSTRUAL, UNSCENTED

Patient Problems Burning Sensation (2146); Unspecified Tissue Injury (4559)

Event Date 11/29/2023

Event Type  Injury  

Event Description

Used honey pot herbal infused period pads.Immediately after wearing, it started burning the interior and exterior tissues of my vagina.I had to remove it and wash the area with water to remove whatever so called herbal ingredients the pad was infused with.My tissue in this area is still tender.This product shouldn't be on the market.

• Brand Name: HONEY POT HERBAL INFUSED PADS
• Type of Device: PAD, MENSTRUAL, UNSCENTED
• Manufacturer (Section D): THE HONEY POT COMPANY LLC.; 1115 howell mill rd nw, suite 750; atlanta GA 30318
• MDR Report Key: 18247454
• MDR Text Key: 329583576
• Report Number: MW5148645
• 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: 11/29/2023

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White