BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXCARE NO STING LIQUID BANDAGE

    MDR report key: 2670290 · Received July 19, 2012

    Report

    Report Number
    2110898-2012-00025
    Event Type
    Injury
    Date Received
    July 19, 2012
    Date of Event
    June 26, 2012
    Report Date
    July 12, 2012
    Manufacturer
    3M CONSUMER HEALTH CARE
    Product Code
    KMF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT IS LABELED: "CONTENTS OF BOTTLE OF STERILE UNTIL OPENED OR USED." CAUTION: DO NOT USE ON LARGE, DEEP OR PUNCTURE WOUNDS, SERIOUS BURNS OR ANIMAL BITES. IF THERE ARE ANY SIGNS OF INFECTION SUCH AS FEVER, PAIN, REDNESS, SWELLING, ITCHING, RASH OR BURNING, DISCONTINUE USE AND CONSIDER CONTACTING A HEALTH CARE PROVIDER. FOR EXTERNAL USE ONLY. KEEP OUT OF REACH OF CHILDREN. AVOID SPRAYING NEAR EYES. NOT FOR USE ON CHRONIC SKIN CONDITIONS. DIRECTIONS: WASH WOUND THOROUGHLY. MAKE SURE WOUND IS CLEAN AND DRY. DO NOT APPLY OINTMENT, CREAM OR LOTION. HOLD BOTTLE OF NEXCARE NO STING LIQUID BANDAGE SPRAY 1 INCH FROM THE WOUND AND SPRAY ON A COAT THAT COVERS THE WOUND. ALLOW TO DRY. TAKES ABOUT 30 SECONDS. APPLY ADDITIONAL COATS IF NEEDED AND ALLOW TO DRY. REPLACE CAP AFTER USE. REAPPLY AS NECESSARY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS SHE USED NEXCARE LIQUID BANDAGE SPRAY ON HER (B)(6) SON ON (B)(6) 2012 TO COVER A SCRAPE FROM SWIMMING IN THE POOL. REPORTEDLY HE CLEANED THE AREA WITH ANTIBACTERIAL SOAP, LET IT DRY, AND THEN USED LIQUID BANDAGE SPRAY. SHE STATED TWO DAYS LATER ((B)(6) 2012) HER SON WAS NOT FEELING WELL. THEY WENT TO THE DOCTOR WHO ADMITTED THE SON TO THE HOSP FOR 3 DAYS FOR POSSIBLE CELLULITIS AND TREATED WITH IV ANTIBIOTICS. THE DOCTOR SAID THE PRODUCT COULD HAVE TRAPPED BACTERIA BUT DID NOT STATE THE INFECTION WAS A DIRECT RESULT FROM USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXCARE NO STING LIQUID BANDAGE 880.5090 LIQUID BANDAGE KMF 3M CONSUMER HEALTH CARE 118-03 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization