BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID BRAND SPORT STRIPS EXTRA WIDE

    MDR report key: 1082470 · Received July 25, 2008

    Report

    Report Number
    8041154-2008-00002
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    JOHNSON & JOHNSON INDUSTRIAL LTDA
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF SUMMARY DATA ASSOCIATED WITH THIS COMPLAINT CATEGORY REVEALED NO ADVERSE TRENDS. OUR PRODUCT HAS LATEX IN THE WRAPPER. ALLERGIC REACTION UNRELATED TO PRODUCT QUALITY. THIS REPORT IS CONSIDERED CLOSED UNLESS ADD'L RELEVANT INFO IS RECEIVED.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT SHE PLACED A BAND-AID ON HER THUMB AREA, WENT INTO ANAPHYLACTIC SHOCK AND WAS TREATED FOR SHOCK AT THE ER. CONSUMER INDICATED THAT SHE NEEDS TO HAVE LATEX FREE BAND-AIDS SO THAT SHE CAN PUT THEM ON HER CHILDREN. SHE CANNOT TOUCH LATEX BAND-AIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAND-AID BRAND SPORT STRIPS EXTRA WIDE ADHESIVE BANDAGE KGX JOHNSON & JOHNSON INDUSTRIAL LTDA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Life Threatening| R