BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTIBACTERIAL FLEXIBLE FABRIC MEDIUM BANDAGES

    MDR report key: 14257495 · Received April 29, 2022

    Report

    Report Number
    MW5109457
    Event Type
    Injury
    Date Received
    April 29, 2022
    Date of Event
    April 21, 2022
    Report Date
    April 27, 2022
    Manufacturer
    WALGREENS BOOTS ALLIANCE, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    USED (B)(6) BRAND ANTIBACTERIAL FLEXIBLE FABRIC MEDIUM (2"X4") BANDAGE WITH 0.8% BENZALKONIUM CHLORIDE (BZK) (ANTISEPTIC) ON (B)(6) MALE'S CHEEK TO TREAT ABRASION. AFTER 36 HOURS OF WEAR, AND UPON REMOVAL USING SOAP AND WATER, VERY SEVERE IRRITANT CONTACT DERMATITIS WAS OBSERVED WITH NO PAIN TO PATIENT. AFTER APPROXIMATELY 12 HOURS OF REST AND LEFT UNCOVERED, THE WOUND LOCATION STILL PRESENTED THE SEVERE REACTION. PEDIATRIC CARE WAS THEN SOUGHT. PEDIATRICIAN RX CETIRIZINE (ZYRTEC) TO COUNTER REACTION. ALSO NOTED THAT SUBJECT BANDAGES CONTAINED 0.8% BZK WHILE CHILDREN'S BANDAGES BY SAME MANUFACTURER CONTAIN 0.1% BZK AS POSSIBLE SOURCE OF IRRITATION. WOUND LOCATION CONTINUES TO HEAL 7 DAYS AFTER LAST USE/REMOVAL OF BANDAGE, WITH OBSERVABLE IMPROVEMENT IN FIRST 24 HOURS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353645 ANTIBACTERIAL FLEXIBLE FABRIC MEDIUM BANDAGES TAPE AND BANDAGE, ADHESIVE KGX WALGREENS BOOTS ALLIANCE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male Other| S CETIRIZINE (ZYRTEC)