MAUDE Adverse Event Report: PROCTOR AND GAMBLE ALWAYS MAXI SOFT AND CLEAN ODOR LOCK

Lot Number 4009478600 42

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Rash (2033); Scar Tissue (2060); Skin Irritation (2076); Numbness (2415); Ambulation Difficulties (2544); Caustic/Chemical Burns (2549); Full thickness (Third Degree) Burn (2696)

Event Date 02/11/2014

Event Type  Injury  

Event Description

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.

• Brand Name: ALWAYS MAXI SOFT AND CLEAN ODOR LOCK
• Type of Device: ALWAYS MAXI SOFT AND CLEAN ODOR LOCK
• Manufacturer (Section D): PROCTOR AND GAMBLE
• MDR Report Key: 3805750
• MDR Text Key: 4370475
• Report Number: MW5036007
• Device Sequence Number: 1
• Product Code: HHD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/21/2014

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 Operator: Other
• Device Lot Number: 4009478600 42
• Other Device ID Number: 010 0230
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/06/2014
• Patient Sequence Number: 1
• Treatment: TOPIRAMATE; SERTRALINE
• Patient Outcome(s): Other; Disability
• Patient Age: 35 YR
• Patient Weight: 48