KOTEX NATURAL BALANCE PANTILINERS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-18 for KOTEX NATURAL BALANCE PANTILINERS manufactured by Kimberly-clark Corp..

Event Text Entries

[16753265] The product is kotex natural balance light days unscented pantiliners. I had a skin reaction including fusing of the skin of the genitals, an abnormal, progressive scar-like condition which occurred between (b)(6), when i stopped using the product. Two doctors believe i will be permanently disfigured by the event. When i stopped using the product the condition began to improve, but two doctors believe that even with medical treatment, it is not likely to be completely reversible. I have been using kotex natural balance light days unscented pantiliners for years with no adverse effects, until buying a box labeled "new and improved," with three new ingredients, identified by kimberly-clark corp. As, "touch of cotton, aloe, and ph aligned -vitamin e-. " no other changes were made to my diet, medications, hygiene products or routine, or other behavior during this period of time, except the "new and improved" kotex liners, which i used daily. The product is not washable, and it comes in direct contact with the sensitive skin of the genitals when used as directed. I have not yet found out what i was exposed to, as the company says their product info is proprietary. I suspect some sort of chemical contamination, possibly herbicide or pesticide on the cotton, aloe, or vitamin e (likely a soy-based vitamin e). If there was a warning of possible skin irritation on the product i would not have purchased it. Reason for use: light, irregular or unpredictable menses. Pro air, albuterol inhaler, as needed (since (b)(6) 2011), for asthma. Before pro air, i used proventil for years, until it was discontinued.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5026577
MDR Report Key2711085
Date Received2012-08-18
Date of Report2012-08-18
Date of Event2012-04-05
Date Added to Maude2012-08-24
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameKOTEX NATURAL BALANCE PANTILINERS
Generic NamePANTILINERS
Product CodeHHD
Date Received2012-08-18
Lot NumberAC202613X2054
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerKIMBERLY-CLARK CORP.


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2012-08-18

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