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

Lot Number	220115-8728
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Burning Sensation (2146)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
I purchased the honey pot company regular pads and within minutes of using the first one i began having an allergic reaction.It began burning to the point where i had to run to change it and even after cleaning the area, it continued to burn.I will have to seek medical attention if symptoms do not stop.The burning sensation has not stopped and it has been multiple hours since use.

• Brand Name: THE HONEY POT COMPANY REGULAR PADS
• Common Device Name: PADS, MENSTRUAL, SCENTED-DEODORIZED
• Manufacturer (Section D): THE HONEY POT COMPANY LLC.
• MDR Report Key: 15156202
• Report Number: MW5111246
• Device Sequence Number: 5966770
• Product Code: NRC
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/01/2022

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?: Yes
• Device Lot Number: 220115-8728
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2022
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 65 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White