STAYFREE OVERNIGHT MAXI SANITARY PADS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-15 for STAYFREE OVERNIGHT MAXI SANITARY PADS manufactured by Mcneil-ppc, Inc..

Event Text Entries

[1726692] I bought stayfree overnight maxi sanitary pads today. I usually buy always, but the store was out and i was in immediate need. Knowing that always has both unscented and "fresh scent" and that i'm allergic to most perfumes, i searched the stayfree label carefully for anything about scent or perfume. Finding nothing and the package not smelling from the outside, i bought the pads and took them home and used one. Well, they do have a light perfume. Now my eyes are itching and my nose is watering, and if i get a rash down, there i'm going to have to go to the hosp. This would have been completely preventable with a simple warning label. Are they in violation of your regulations? If not, can we make such a regulation? Don't makers of personal paper products have to prominently display the presence of perfume if they use such? Personally, i think they should be forbidden to use perfume. How ridiculous. Those who want to smell like a flower can choose a perfume to wear. With these things, they are increasing the risks of allergic reactions in their customers, for what? So that if someone puts his head in my lap he can comment on how nice i smell down there, if it doesn't choke him up the way it does me? Ugh. Please tell me what i can do so that stayfree is sanctioned, and if you need the package for your investigation or i can return it to the store tomorrow and get my money back, if i live through the night. Please respond via e-mail. Thank you.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5019063
MDR Report Key1969285
Date Received2011-01-15
Date of Report2011-01-15
Date of Event2011-01-15
Date Added to Maude2011-02-02
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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameSTAYFREE OVERNIGHT MAXI SANITARY PADS
Generic NameSTAYFREE OVERNIGHT MAXI SANITARY PADS
Product CodeHHL
Date Received2011-01-15
Lot Number2990M0143
ID Number8004-073900
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerMCNEIL-PPC, INC.
Manufacturer AddressSKILLMAN NJ 08558 US 08558


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-01-15

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