BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID BRAND ADHESIVE BANDAGES DISNEY FROZEN

    MDR report key: 5491141 · Received March 9, 2016

    Report

    Report Number
    2214133-2016-00001
    Event Type
    Injury
    Date Received
    March 9, 2016
    Date of Event
    November 1, 2015
    Report Date
    February 12, 2016
    Manufacturer
    SKILLMAN CONTRACT
    Product Code
    KGX
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(6) 2016. THIS IS AN INITIAL SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 2214133-2016-00001. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IN THIS CASE IS 2214133-2016-00002. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS (B)(6) 2016. THIS IS FOLLOW UP SUBMISSION FOR THE FIRST PRODUCT IN THIS CASE. THE MANUFACTURER REPORT NUMBER FOR THIS SUBMISSION IS 2214133-2016-00001. THE MANUFACTURER REPORT NUMBER FOR THE SECOND PRODUCT IN THIS CASE IS 2214133-2016-00002. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2016 FROM A (B)(6) CAUCASIAN FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES OF AMERICA. THE MEDICAL HISTORY INCLUDED AN UMBILICAL HERNIA REPAIR.. THE CONSUMER HAD ALLERGIES TO SULFA AND ERYTHROMYCIN. THE CONCOMITANT MEDICATIONS INCLUDED JUICE PLUS, SOTE ROOT (SIC), MAGNESIUM, CALCIUM, VITAMIN D, MULTI-VITAMIN AND PROBIOTICS, ALL MEDICATIONS WERE TAKEN FOR YEARS FOR GENERAL HEALTH. THE REPORTED WEIGHT OF THE CONSUMER WAS (B)(6). ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING BAND-AID BRAND ADHESIVE BANDAGES DISNEY FROZEN AND BAND-AID BRAND ADHESIVE BANDAGES MUTANT NINJA TURTLES, CUTANEOUSLY TO COVER OPEN WOUNDS, WHICH WERE WEEPING FROM CONTACT DERMATITIS ON HER LEG (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED FOR BOTH DEVICES). SHE APPLIED THE BANDAGES AND ENSURED THE BANDAGE TABS DID NOT TOUCH THE OPEN WOUND. AFTER AN UNSPECIFIED DURATION, UPON REMOVAL OF THE BANDAGES SHE NOTICED NEW PATCHES OF CONTACT DERMATITIS WHERE THE BANDAGE ADHESIVE TOUCHED THE SKIN ON HER LEG. THE CONSUMER STATED SHE CONSULTED A DERMATOLOGIST MULTIPLE TIMES SINCE (B)(6) 2015. A SKIN BIOPSY WAS PERFORMED AND CONFIRMED CONTACT DERMATITIS. ON AN UNSPECIFIED DATE IN (B)(6) 2015, BOTH THE DEVICES WERE DISCONTINUED. ALLERGY TESTING CONFIRMED ALLERGIES TO PROPYLENE GLYCOL AND CARBA MIX. AFTER UNSPECIFIED DURATION IN (B)(6) 2016, THE CONSUMER CONSULTED AN ALLERGIST AND ALLERGY TESTING CONFIRMED ALLERGIES TO PROPYLENE GLYCOL AND CARBA MIX. SHE WAS ADVISED TO AVOID CONTACT WITH PROPYLENE GLYCOL AND CARBA MIX, WHICH IS USED IN LATEX, RUBBER, AND ADHESIVES. SHE USED NEOSPORIN (BACITRACIN, NEOMYCIN AND POLYMYXIN B), UNSPECIFIED HEALING OILS, UNSPECIFIED STEROID TOPICAL CREAMS AND UNSPECIFIED STEROID INJECTIONS TO TREAT THE EVENTS. THE CONSUMER MENTIONED, THE BANDAGES DID NOT CAUSE THE INITIAL REACTION, BUT AFTER USING THE BANDAGES, THE CONTACT DERMATITIS SEEMED TO SPREAD. EITHER IN (B)(6) 2016, THE EVENT RESOLVED. FOR BOTH THE DEVICES, THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2016 FROM A (B)(6) YEAR OLD (B)(6) FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES OF AMERICA. THE MEDICAL HISTORY INCLUDED AN UMBILICAL HERNIA REPAIR. THE CONSUMER HAD ALLERGIES TO SULFA AND ERYTHROMYCIN. THE CONCOMITANT MEDICATIONS INCLUDED JUICE PLUS, SOTE ROOT (SIC), MAGNESIUM, CALCIUM, VITAMIN D, MULTI-VITAMIN AND PROBIOTICS, ALL MEDICATIONS WERE TAKEN FOR YEARS FOR GENERAL HEALTH. THE REPORTED WEIGHT OF THE CONSUMER WAS (B)(6) KILOGRAMS. ON AN UNSPECIFIED DATE, THE CONSUMER STARTED USING (B)(6) BRAND ADHESIVE BANDAGES (B)(6) AND (B)(6) BRAND ADHESIVE BANDAGES (B)(6), CUTANEOUSLY TO COVER OPEN WOUNDS, WHICH WERE WEEPING FROM CONTACT DERMATITIS ON HER LEG (FREQUENCY, LOT NUMBER AND EXPIRATION DATE UNSPECIFIED FOR BOTH DEVICES). SHE APPLIED THE BANDAGES AND ENSURED THE BANDAGE TABS DID NOT TOUCH THE OPEN WOUND. AFTER AN UNSPECIFIED DURATION, UPON REMOVAL OF THE BANDAGES SHE NOTICED NEW PATCHES OF CONTACT DERMATITIS WHERE THE BANDAGE ADHESIVE TOUCHED THE SKIN ON HER LEG. THE CONSUMER STATED SHE CONSULTED A DERMATOLOGIST MULTIPLE TIMES SINCE (B)(6) 2015. A SKIN BIOPSY WAS PERFORMED AND CONFIRMED CONTACT DERMATITIS. ON AN UNSPECIFIED DATE IN (B)(6) 2015, BOTH THE DEVICES WERE DISCONTINUED. ALLERGY TESTING CONFIRMED ALLERGIES TO PROPYLENE GLYCOL AND CARBA MIX. AFTER UNSPECIFIED DURATION IN (B)(6) 2016, THE CONSUMER CONSULTED AN ALLERGIST AND ALLERGY TESTING CONFIRMED ALLERGIES TO PROPYLENE GLYCOL AND CARBA MIX. SHE WAS ADVISED TO AVOID CONTACT WITH PROPYLENE GLYCOL AND CARBA MIX, WHICH IS USED IN LATEX, RUBBER, AND ADHESIVES. SHE USED NEOSPORIN (BACITRACIN, NEOMYCIN AND POLYMYXIN B), UNSPECIFIED HEALING OILS, UNSPECIFIED STEROID TOPICAL CREAMS AND UNSPECIFIED STEROID INJECTIONS TO TREAT THE EVENTS. THE CONSUMER MENTIONED, THE BANDAGES DID NOT CAUSE THE INITIAL REACTION, BUT AFTER USING THE BANDAGES, THE CONTACT DERMATITIS SEEMED TO SPREAD. EITHER IN (B)(6) 2016 OR IN (B)(6) 2016, THE EVENT RESOLVED. FOR BOTH THE DEVICES, THE COMPLAINT INVESTIGATION WAS CLOSED WITH A DISPOSITION OF UNDETERMINED. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION) AND COMPANY CAUSALITY WAS ASSESSED AS RELATED. ADDITIONAL INFORMATION WAS RECEIVED FROM PHYSICIAN ON (B)(6) 2016. THE PHYSICIAN STATED THE CONSUMER WAS (B)(6) YEARS OLD AND HAD A MEDICAL HISTORY OF DERMATITIS AND ALLERGY TO SULFA ANTIBIOTICS. THE REPORTED HEIGHT OF THE CONSUMER WAS (B)(6) CENTIMETERS. IN (B)(6) 2015 THE CONSUMER DEVELOPED IRRITATION AND RASH WHERE THE BANDAGES WERE APPLIED. THE EVENTS RESOLVED. THE CAUSALITY RELATED TO THE DEVICE WAS ASSESSED AS POSSIBLE BY THE PHYSICIAN. THIS REPORT REMAINS SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146016 BAND-AID BRAND ADHESIVE BANDAGES DISNEY FROZEN TAPE AND BANDAGE, ADHESIVE KGX SKILLMAN CONTRACT BADFZBUS N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention