KOTEX U NIGHT TIME PADS KOTEX U ALLNIGHTER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-03-20 for KOTEX U NIGHT TIME PADS KOTEX U ALLNIGHTER manufactured by .

Event Text Entries

[2574323] Document (b)(4). It started when i bought kotex u night time pads. I used it for the first time on saturday night and by monday i noticed a large bump on my left buttocks, by tuesday morning, i had a severe rash the exact same size and shape as the pad. I went to the dr who had to put me on 2 different antibiotics due to risk of staph infection. By wednesday, my rash has swollen 3 times the size and started seeping. My dr sent me straight to er where they injected me with a steroid and sent me home on 2 different steroids. They told me not to return to work until monday due to significant infection, i called kotex/kimberly clark and spoke to (b)(4) who assured me that she's never heard of this; however, when i investigated i found that on kotex's own web site (www. Community. Kotex. Com) that there are many people with similar horror stories. Now i have to go see a dermatologist tomorrow. After 2 drs appointments, and er visit, over (b)(6) in medication and 2 days off work without pay i am furious, in extreme pain, embarrassed and highly disappointed from a feminine product that not only doesn't list the ingredients of their product, but appalled that feminine product do not have to label themselves as hypo allergenic or non-hypo allergenic. And fyi- i've never had any allergies or sensitivities prior to this so whatever kotex is using (made in (b)(6)) is obviously not safe for all women. Retailer: (b)(6). Purchase date: (b)(6) 2012. The product was not damaged before the incident. The product was not modified before the incident. Report#: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5024712
MDR Report Key2501037
Date Received2012-03-20
Date of Report2012-03-09
Date of Event2012-03-05
Date Added to Maude2012-03-26
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 U NIGHT TIME PADS
Generic NamePAD
Product CodeHHD
Date Received2012-03-20
Model NumberKOTEX U ALLNIGHTER
Device AvailabilityY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2012-03-20

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