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 NumberMW5036007
MDR Report Key3805750
Date Received2014-05-06
Date of Report2014-04-21
Date of Event2014-02-11
Date Added to Maude2014-05-13
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameALWAYS MAXI SOFT AND CLEAN ODOR LOCK
Generic NameALWAYS MAXI SOFT AND CLEAN ODOR LOCK
Product CodeHHD
Date Received2014-05-06
Lot Number4009478600 42
ID Number010 0230
Device Sequence No1
Device Event Key0
ManufacturerPROCTOR AND GAMBLE


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Deathisabilit 2014-05-06

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