EQUATE EVERYDAY LINERS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-01 for EQUATE EVERYDAY LINERS manufactured by Unk.

Event Text Entries

[90879823] I bought feminine liners from (b)(6) and its a generic brand (equate). What i've been noticing is a rash appearing on my bikini line. I'm allergic to latex and before purchasing this product, i had been using always liners and thought it could have been a reaction from their line. It was actually from my detergent. But for this equate product, after putting it on and having wearing it and frequent changes, the rashes are more frequent, as in all the time. During the day and even at bedtime, i have to scratch and it would hurt because i've scratched the layer of my skin. I haven't brought this up to my doctor yet but i would like to know firsthand if this product has any latex either on the top layer or for its adhesive in the back. This is something my doctor knows that i am allergic to latex. . I've given the box to my sister whom she has no side effects using them. If you need to know what product i am referring to, it is the equate everyday liners (long) 108 count compared to always. Barcode (b)(4). There's a number stamp underneath also (b)(4). Date the person first started taking or using the product: (b)(6) 2017. Date the person stopped taking or using the product: (b)(6) 2017. 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: yes. Cheaper brand.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073074
MDR Report Key6993582
Date Received2017-11-01
Date of Report2017-10-28
Date of Event2017-10-16
Date Added to Maude2017-11-01
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameEQUATE EVERYDAY LINERS
Generic NamePAD, MENSTRUAL
Product CodeHHL
Date Received2017-11-01
Lot Number17 122
ID NumberNDC # K80B
Device AvailabilityY
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2017-11-01

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