BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAND-AID BRAND LIQUID BANDAGE

    MDR report key: 460273 · Received April 28, 2003

    Report

    Report Number
    2243656-2003-00001
    Event Type
    Other
    Date Received
    April 28, 2003
    Date of Event
    May 15, 2002
    Report Date
    April 21, 2003
    Manufacturer
    JOHNSON & JOHNSON CONSUMER COMPANIES, INC.
    Product Code
    KMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THEY BUMPED THE RIGHT SIDE OF THEIR RIGHT FOOT AND SUSTAINED A SMALL LACERATION. CONSUMER STATED THAT THEY APPLIED A JOHNSON & JOHNSON BAND-AID BRAND ADHESIVE BANDAGE TO THE CUT, BUT THE BANDAGE KEPT RUBBING INSIDE THEIR SHOE, RESULTING IN IRRITATION. CONSUMER NEXT PURCHASED BAND-AID BRAND LIQUID BANDAGE AND APPLIED IT AS PER THE PACKAGE DIRECTIONS TO THEIR CUT AND THE IRRITATED AREA. IN THEIR WORDS, THE CONSUMER STATED THAT THEY REMOVED THE PRODUCT ABOUT 2-3 DAYS LATER WITH BABY OIL AS PER THE PACKAGE DIRECTIONS, AND THE LIQUID BANDAGE ALLEGEDLY REMOVED SEVERAL LAYERS OF SKIN. CONSUMER FURTHER REPORTED THAT THE IRRITATED AREA WAS ULCERATED. CONSUMER SAW THEIR FAMILY DOCTOR WHO ALLEGEDLY REFERRED THE CONSUMER TO A PODIATRIST. THE PODIATRIST ALLEDGEDLY DIAGNOSED AN INFECTED ULCER, WITH YELLOW DRAINAGE FROM THE WOUND. ALLEDEDLY, THE PODIATRIST PRESCRIBED SILVADENE CREAM AND ORAL ANTIBIOTICS. CONSUMER STATED THAT THE WOUND DID NOT HEAL AND THEY WENT BACK TO THE PODIATRIST. CONSUMER ASSERTS THAT ANOTHER ROUND OF ORAL ANTIBIOTICS WAS PRESCRIBED AND THAT WEEKLY OFFICE VISITS WERE REQUIRED. IN THEIR WORDS, IT WAS VERY PAINFUL. CONSUMER REPORTED THAT THE SORE WAS THEN HEALING AND WAS WHITER THAN THE SURROUNDING SKIN. CONSUMER STATED THAT THEY WERE CONCERNED BECAUSE THE DOCTOR ALLEGEDLY SUGGESTED THAT HE HAS SEEN ANOTHER REACTION RELATED TO THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAND-AID BRAND LIQUID BANDAGE LIQUID BANDAGE KMF JOHNSON & JOHNSON CONSUMER COMPANIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other PRILOSEC.