BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID BRAND SHEER COMFORT FLEX BAN

    MDR report key: 822984 · Received February 23, 2007

    Report

    Report Number
    2243656-2007-00001
    Event Type
    Injury
    Date Received
    February 23, 2007
    Date of Event
    January 16, 2006
    Report Date
    February 21, 2007
    Manufacturer
    JOHNSON & JOHNSON CONSUMER COMPANIES, INC.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RECORDS EVALUATED, NO TRENDS IDENTIFIED. THIS MDR IS BEING SUBMITTED BASED ON AN INTERNAL AUDIT OF OUR MDR PROCESS. THE CASE WAS REEVALUATED AND DETERMINED TO HAVE BEEN REPORTABLE. THIS REPORT IS CONSIDERED CLOSED UNLESS ADD'L RELEVANT INFO IS REC'D. CORRECTED ERROR IN MFR REPORT NUMBER. CHANGED FROM 2243656-2001-00001 TO 2243656-2007-00001.

    Description of Event or Problem · 1

    CONS WITH KNOWN LATEX ALLERGY PUT 2 BANDAIDS ON BELLY BUTTON, NOTICED ITCHING WITHIN MINS, TWO HRS LATER, SHE REMOVED BANDAIDS AND HAD RED BLISTERS UNDER THE BANDAIDS. USED EPI PEN. DEVELOPED BEGINNING SIGN OF THROAT CLOSING AND SOB. CONTACTED HCP BY PHONE. TX WITH AN INCREASED DOSE OF HER DAILY PREDNISONE. SYMPTOMS ABATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAND-AID BRAND SHEER COMFORT FLEX BAN ADHESIVE BANDAGE KGX JOHNSON & JOHNSON CONSUMER COMPANIES, INC. NA 1455B

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other CLIMARA PATCH| PREDNISONE.