MAUDE MDR 2711085

MDR report key
2711085
Report number
MW5026577
Event key
0
Event type
3
Date of event
2012-04-05
Date received
2012-08-18
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KOTEX NATURAL BALANCE PANTILINERSPANTILINERSKIMBERLY-CLARK CORP.HHDAC202613X2054 Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-08-1801. S

Event Narratives#

D

Patient 1

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.