STAY FREE CLASSIC SUPER LONG PADS (BLUE PACKAGE)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-20 for STAY FREE CLASSIC SUPER LONG PADS (BLUE PACKAGE) manufactured by Playtex Manufacturing Inc..

Event Text Entries

[112062449] Put on the improved stayfree pad, and my face began to flush, and i began to feel as though i was experiencing an allergic reaction. I removed the pad and used soap and water, and in about 15 to 20 minutes the reaction subsided. I then called the company, and they stated they had added more absorbent gel to the pad - so evidently i'm allergic to the gel. That's when i contacted you all in case you needed to investigate the cement of the gel they are using. Currently using an all natural organic pad by free and clear - seventh generation - made by seventh generation, inc, (b)(4). They are wonderful - no problem at all. I believe all companies should go organic and not use gels. Also, have problem with formaldehyde - be good if they would leave it out of hairsprays, shampoo, cosmetics and household - wood floors and paneling. Distributed by (b)(4). Did the problem stop after the person reduced the dose or stopped taking or using the product: yes. Did the problem return if the person started taking or using the product again: didn't restart. Why was the person using the product: using for bladder leakage. Allergic reaction to stayfree feminine pads (due to more added gel).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5077965
MDR Report Key7624658
Date Received2018-06-20
Date of Event2018-05-01
Date Added to Maude2018-06-21
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 FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSTAY FREE CLASSIC SUPER LONG PADS (BLUE PACKAGE)
Generic NameSTAY FREE CLASSIC SUPER LONG PADS (BLUE PACKAGE)
Product CodeNRC
Date Received2018-06-20
Lot Number1806408400
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerPLAYTEX MANUFACTURING INC.


Patients

Patient NumberTreatmentOutcomeDate
10 2018-06-20

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