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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WALGREEN CO. / KAZ USA, INC., A HELEN OF TRAY COMPANY NON-STICK PADS WITH ADHESIVE TABS; TAPE AND BANDAGE, ADHESIVE
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WALGREEN CO. / KAZ USA, INC., A HELEN OF TRAY COMPANY NON-STICK PADS WITH ADHESIVE TABS; TAPE AND BANDAGE, ADHESIVE Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Erythema (1840); Foreign Body Reaction (1868); Itching Sensation (1943); Scarring (2061); Injury (2348)
Event Date 11/04/2019
Event Type  Injury  
Event Description
Walgreens non-stick pads with adhesive tabs state that they are "not made with natural rubber latex." i have what i understood to be a mild rubber latex allergy, so chose these to cover a scrape.After a few days of using them, changing the pads each day, i developed red, itchy welts where the adhesive contacted my skin, and which were much worse than the original injury.I discontinued the use, but the red welts did not get any better, so i went to see my dr after a week, and she diagnosed dermatitis due to the allergy from a product that was supposed to be made without the allergan.My dr is concerned that these will scar permanently, and has prescribed a steroid cream, a pain relief cream, and a scar cream, mederma.Fda safety report id# (b)(4).
 
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Brand Name
NON-STICK PADS WITH ADHESIVE TABS
Type of Device
TAPE AND BANDAGE, ADHESIVE
Manufacturer (Section D)
WALGREEN CO. / KAZ USA, INC., A HELEN OF TRAY COMPANY
MDR Report Key9384363
MDR Text Key168460476
Report NumberMW5091343
Device Sequence Number1
Product Code KGX
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/26/2019
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age44 YR
Patient Weight91
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