MAUDE Adverse Event Report: THE HONEY POT COMPANY, LLC. HONEY POT REGULAR COTTON MENSTRUAL PAD WITH WINGS; PADS, MENSTRUAL, SCENTED-DEODORIZED

Medical Device Problem Codes	Product Quality Problem (1506); Chemical Problem (2893)
Health Effect - Clinical Codes	Pain (1994); Burning Sensation (2146)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
I used honey pot brand organic cotton regular pads with wings.As soon as i put it on, i felt a strange tingling feeling in my vulva, that then worsened to a painful burning feeling.I finally had to remove the pad and wash the area with water before the burning sensation began to abate.On further investigation, i saw that the pads contain "essential oils", and an internet search showed that many users had experienced vulvar pain and burning after using these products.For menstrual bleeding.

• Brand Name: HONEY POT REGULAR COTTON MENSTRUAL PAD WITH WINGS
• Common Device Name: PADS, MENSTRUAL, SCENTED-DEODORIZED
• Manufacturer (Section D): THE HONEY POT COMPANY, LLC.
• MDR Report Key: 15825719
• Report Number: MW5113365
• Device Sequence Number: 11642726
• Product Code: NRC
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• 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): 11/16/2022

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 Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/17/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White