BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAD-AID BRAND ADHESIVE BANDAGES FLEXIBLE

    MDR report key: 736506 · Received July 14, 2006

    Report

    Report Number
    2243656-2006-00001
    Event Type
    Injury
    Date Received
    July 14, 2006
    Date of Event
    June 1, 2006
    Report Date
    July 7, 2006
    Manufacturer
    JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER ACTION IS REQUIRED BASED ON THE INFORMATION RECEIVED. THIS REPORT IS CONSIDERED CLOSED UNLESS NEW INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    CONSUMER REPORTED: WITHIN SECONDS OF OPENING PROD, DEVELOPED RASH ON BOTH HANDS / ADMITTED TO HOSPITAL OVERNIGHT / SX ABATED, SEE NOTES. CONSUMER REPORTS USED THE PRODUCT "SOMETIME LAST WEEK" (ONE WEEK IN 2006), BUT "COULD NOT REMEMBER THE EXACT DAY". CONSUMER REPORTS APPLYING THE PRODUCT TO HER LEFT THUMB TO COVER "A SMALL CUT". CONSUMER REPORTS "WITHIN SECONDS" OF OPENING THE WRAPPER, BOTH OF HER HANDS "INSTANTLY" DEVELOPED A BRIGHT RED RASH. CONSUMER REPORTS THAT DUE TO HER KNOWN ALLERGIES, SHE CARRIES AN EPI-PEN. CONSUMER REPORTS THAT "ONCE MAY FRIEND SAW MY HANDS, SHE GAVE ME AN INJECTION IN MY LEG". CONSUMER DENIES DIFFICULTY BREATHING OR ANY SHORTNESS OF BREATH. CONSUMER STATED THAT THE RASH WAS JUST PRESENT ON HER HANDS. CONS REPORTS SX PERSIST FOR "OVER TWO HOURS". UNDER THE ADVISE OF HER PARENTS, CONSUMER WENT TO LOCAL ER FOR TREATMENT. CONSUMER REPORTS THAT "I DON'T REMEMBER IF THEY GAVE ME ANOTHER INJECTION OR NOT". CONSUMER REPORTS THAT SHE WAS KEPT ADMITTED TO THE HOSPITAL OVERNIGHT FOR "OBSERVATION". CONSUMER STATED THAT THE ER HCP WANTED TO "MAKE SURE I DIDN'T NEED ADDITIONAL EPI". CONSUMER WAS RELEASED FROM HOSPITAL W/O TX AND ADVISED TO F/U WITH HCP. CONSUMER REPORTS THAT ALL SX HAVE ABATED AT THIS TIME. DISCUSSED INDIVIDUAL SENSITIVITIES. ADVISED CONSUMER TO F/U WITH HCP FRN. ADVISED CONSUMER THAT ROI, PPE, AND QM WOULD BE ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAD-AID BRAND ADHESIVE BANDAGES FLEXIBLE TAPE AND ADHESIVE BANDAGE KGX JOHNSON & JOHNSON CONSUMER PRODUCTS COMPANY NA 2705F

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization ADVAIR| SINGULAIR