REGULAR FEMININE PADS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for REGULAR FEMININE PADS manufactured by The Honey Pot Company Llc.

Event Text Entries

[185737822] I purchased the feminine pads by the honey pot company and tried the product for the first and last time on (b)(6). Shortly the burning sensation started that make me feel very uncomfortable and irritated. I could not change out the pad, as i was in a public place for 2 hours so i had to tolerate the side effect for all that time. As soon as i got to the private place i changed out the pad and showered. The burning sensation did not go away. I discontinued using these pads right away. This was monday, (b)(6). By wednesday, (b)(6) the effects have worsened - itching, burning and huge discomfort. I had to seek med examination. My dr ordered lab results which confirmed that i developed bacterial vaginosis due to this horrible product. My dr looked at the packaging and the pads and could not believe it - they advertise it as "herb-infused", but in reality they use mint essential oils on the surface of the pads, i mean why would you do this and apply mint on the product that will be used on the sensitive area? I had to use medication to get rid of bv and f/u with my dr on this condition that caused me great discomfort and health harm. Please do something about the honey pot company and do not allow them to sell these horrible products that actually damage women's health on the market. I tried reaching out to them on social media telling them what happened. The only response i got from them was: "we're sorry you experienced a negative reaction. Some consumers are sensitive to essential oils. We recommend you discontinue use. " awesome, right. You are my only hope that something can be done in order to preserve women's health and not spread the products widely on the market that are dangerous. I provided all applicable details in the description of the issue above. Why was the person using the product? For the direct usage advertised. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093965
MDR Report Key9897329
Date Received2020-03-27
Date of Report2020-03-26
Date of Event2020-03-09
Date Added to Maude2020-03-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameREGULAR FEMININE PADS
Generic NamePADS, MENSTRUAL, SCENTED-DEODORIZED
Product CodeNRC
Date Received2020-03-27
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerTHE HONEY POT COMPANY LLC
Manufacturer Address400 WEST PEACHTREE STREET NW STE 710 ATLANTA GA 30308 US 30308


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-27

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