• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Pain (1994); Rash (2033); Skin Irritation (2076); Swelling (2091); Discomfort (2330); Impaired Healing (2378); Fungal Infection (2419)
Event Type  Injury  
Event Description
I have been experiencing reoccurring skin problems including: lesions, rashes, eczema, infections, etc for over 2 years in my vaginal and anal regions. I have been repeatedly diagnosed and treated for yeast infections and ring worm but it keeps reoccurring. The skin problems have made intimacy close to impossible as i experience lesions which take several days to heal. It wasn't until i did research on my own that i came across several blogs discussing my same symptoms which were being attributed to methylisothiazolinone. This really got my attention because i am regular user of flushable wipes, thinking they were making a clean and helping me with any bacterial/fungal infections. I decided to test the theory of having an allergic reaction by eliminating the use of products containing methylisothiazolinone. It was only a matter of days before i started experiencing relief from the numerous skin problems that i had been battling for years. I couldn't believe how such a simple change would make such a serious difference for me. Since discontinuing my use of products containing methylisothiazolinone, i have been symptom free. In reading more about this chemical, i now understand that it has been banned in several countries for use in cosmetic and personal care products. I can't believe it, along with its other variations, are still being allowed in the united states. And further, that there are no warnings about possible problems arising from its use. I can't believe that i went through years of pain and discomfort from using products that were designed for my personal care and hygiene. I think allowing these chemicals to continue being used in products to be irresponsible. I hope my information will lead to more research and regulations to remove these toxic chemicals from being used in the united states. No one else should have to suffer with no answers for as long as i have. Reason for use: personal cleansing.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

MDR Report Key5620534
MDR Text Key44157143
Report NumberMW5061998
Device Sequence Number1
Product Code NEC
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 03/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 04/26/2016 Patient Sequence Number: 1