LE CLEANSING CLOTHS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-06 for LE CLEANSING CLOTHS manufactured by Kimberly Clark.

Event Text Entries

[40052333] 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 repeated 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 there were making me 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 have 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 was 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 what 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 info 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5060790
MDR Report Key5489886
Date Received2016-03-06
Date of Report2016-03-06
Date Added to Maude2016-03-09
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 Report0

Device Details

Brand NameLE CLEANSING CLOTHS
Generic NameCOTTONELLE CLEANSING CLOTHS
Product CodeLDQ
Date Received2016-03-06
Device AvailabilityY
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerKIMBERLY CLARK


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-03-06

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