STAYFREE ULTRA THIN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-29 for STAYFREE ULTRA THIN manufactured by Johnson & Johnson.

Event Text Entries

[19366838] As a result of a surgical excision in the doctor's office and resulting spotting. I had to purchase female hygiene sanitary pads for the first time in 12 years. I purchased stayfree ultra thin. For the past 5 days, i have been suffering from an excruciatingly painful rash on my derriere - it is beet red, inflamed, and has some pustules. Nothing i've been doing has gotten rid of this yet. At various times, i've tried hot baths, neosporene, vaseline, baby cornstarch, and benadryl. In addition, i've washed all clothing and bed linens that may have come in contact with the pads. I can't wait for my doctor's appointment in 2 days to see if he can prescribe something that will relieve this. On the day i first suspected the pad, i immediately removed it and cleaned the area with fragrant free soap. Throughout the day, while i was at work, the rash just intensified. I suspect the irritating ingredient was still on my underwear. I cannot believe that a company is permitted to sell a product that causes such grief to a consumer. A search of the internet shows that i am not alone. Please, please do something to remove this product from the shelf before any more women have to suffer. P. S. In completing this form, it wouldn't let me proceed or submit without checking all kinds of boxes that don't apply. Dates of use: 3 days, (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5027126
MDR Report Key2771727
Date Received2012-09-29
Date of Report2012-09-29
Date of Event2012-09-26
Date Added to Maude2012-10-05
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 NameSTAYFREE ULTRA THIN
Generic NameSTAYFREE ULTRA THIN
Product CodeNRC
Date Received2012-09-29
Lot NumberM1731M3007 3 14:35
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerJOHNSON & JOHNSON
Manufacturer AddressSKILLMAN NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-09-29

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