ALWAYS MAXI SOFT AND CLEAN ODOR LOCK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-05-06 for ALWAYS MAXI SOFT AND CLEAN ODOR LOCK manufactured by Proctor And Gamble.

Event Text Entries

[4370475] On (b)(6) 2014, i bought always pads from (b)(4). I put one on at school. About an hour into my class i felt some irritation on my bottom. Within a few days, i broke out with full blown blisters from the front of my vagina to the back of my bottom. The blisters were in the exact pattern of the pad. They were so painful i could barely sleep, walk or take a shower. I took pictures of the scars they left. They were so painful. I couldn't care for my 3 children, sit during my classes, or do household chores. My dr. Thinks i got 3rd degree chemical burns from the chemical in the pad. She gave me aloe vera with lidocaine and silver sulfadiazine cream to ease the pain. This lasted for more than a month. Now that im healed, the left side of my vagina, and inside my anus where the chemical had gotten is completely numb. I have no feeling left at all from the chemical burns. I have the package of pads. I have the receipts, i have pictures, my test results and a journal. This happened over valentines day weekend and destroyed the entire month of (b)(4). Please call or email if you have any further questions. I would hate for this to happen to someone else or for a child to get a hold of these. Diagnosis or reason for use: used during period.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5036007
• MDR Report Key: 3805750
• Date Received: 2014-05-06
• Date of Report: 2014-04-21
• Date of Event: 2014-02-11
• Date Added to Maude: 2014-05-13
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ALWAYS MAXI SOFT AND CLEAN ODOR LOCK
• Generic Name: ALWAYS MAXI SOFT AND CLEAN ODOR LOCK
• Product Code: HHD
• Date Received: 2014-05-06
• Lot Number: 4009478600 42
• ID Number: 010 0230
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PROCTOR AND GAMBLE

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Deathisabilit	2014-05-06