MAUDE Adverse Event Report: ESSITY CANADA INC. TENA, EQUATE OPTIONS WALMART; GARMENT, PROTECTIVE, FOR INCONTINENCE

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Rash (2033); Scar Tissue (2060); Chemical Exposure (2570); Skin Disorders (4543)

Event Date 12/10/2021

Event Type  Injury  

Event Description

I began experiencing erythema multiforme from head to toe in (b)(6) 2021.I was treated 3 separate times by a dermatologist.Massive doses of oral/topical steroids were given each time in (b)(6), (b)(6), and (b)(6).The rash would slightly abate only to return again upon cessation of steroids.All detergent, soap, toothpaste, deodorant, shampoo/conditioner ect.Were changed to hypoallergenic with no effect.Medicine was changed to make sure it was not a food dye used in my levothroxine/unithroid.Again no effect on the rash.At the beginning of (b)(6) i suddenly noticed that the "pads" i use daily for "stress incontinence", worsened the symptoms! i put two and two together.I use a few different brands (tena, options/ equate walmart brand) the pads are "unscented", how ever they have something in them called "odor guard", and "odor control".I found a brand from amazon made in (b)(6), designed by koreans (rael) that was one of the only pads that did not contain this "additive" to mask odor.I have used them now exclusively for a month, and am happy to report that my symptoms stopped within days of the switch, and my skin is now healing at last.I experienced severe scarring of my skin from this experience.I have read that these chemicals are in adult diapers as well, and the thought that the elderly are using them, and possibly having this sort of a reaction without understanding why is what has led me to write to you.I shudder at the thought of the suffering this has caused.My skin is permanently damaged.I saw that one of the companies that manufacture these tried for eight years to get a patent on this "additive/chemical", and finally withdrew the request.The "unscented" nomenclature leads a consumer to believe somehow this is a good thing, but the fact that there is something inside the pads that is a chemical to mask the smell of the urine without ever explaining what that chemical additive is, is a travesty.I will continue to use the product i have found, as i cannot believe my very expensive, body altering experience has come to an end.Thank-you for your time, and i hope you can look into this matter.There were 3 separate visits to a(b)(6) dermatologist professor; 12/2021-06/2022 a skin biopsy was also performed.3 rounds of high dose regimens of prednisone, and topical kenalog were prescribed.

• Brand Name: TENA, EQUATE OPTIONS WALMART
• Type of Device: GARMENT, PROTECTIVE, FOR INCONTINENCE
• Manufacturer (Section D): ESSITY CANADA INC.
• MDR Report Key: 15328108
• MDR Text Key: 299058379
• Report Number: MW5111814
• Device Sequence Number: 1
• Product Code: EYQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: UNITHROID 0.88MCG
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White