BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAND-AID BRAND AHESIVE BANDAGES FLEXIBLE FABRIC

    MDR report key: 4202550 · Received October 27, 2014

    Report

    Report Number
    8041154-2014-00003
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 6, 2014
    Manufacturer
    BRAZIL CONSUMER
    Product Code
    KGX
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS SUBMISSION IS 27-OCT-2014. THIS CLOSES OUT THIS REPORT UNLESS OTHER ADDITIONAL SIGNIFICANT INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2014 FROM A (B)(6)-YEAR-OLD FEMALE CONSUMER REPORTING ON SELF FROM THE UNITED STATES. THE MEDICAL HISTORY INCLUDED ANAPHYLACTIC SHOCK (PETROLEUM AND WHITE POTATOES), THUMB NAIL REMOVAL AND ALLERGIES TO PETROLEUM BASED PRODUCTS, CORN OR CORN DERIVATIVES, YEAST, WHITE POTATOES, PROCESSED FOODS, SOY, SALMON, PORK, PECAN, PISTACHIOS, MUSHROOMS, SCALLOPS, COCOA, ARTIFICIAL SWEETENERS, MANY UNSPECIFIED MEDICATIONS AND OTHER UNSPECIFIED ALLERGIES. SHE WAS NOT TAKING ANY CONCOMITANT MEDICATION. THE SOCIAL HISTORY INCLUDED CIGARETTE SMOKING. ON (B)(6) 2014, THE CONSUMER'S DOCTOR APPLIED BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC (LOT NUMBER AND EXPIRATION DATE UNSPECIFIED) CUTANEOUSLY, ONE BANDAGE, ONCE, TO COVER A WOUND ON THE CONSUMER'S THUMB AFTER THUMB NAIL REMOVAL. AFTER LEAVING THE DOCTOR'S OFFICE, SHE PURCHASED A BOX OF BAND-AID BRAND ADHESIVE BANDAGES FLEXIBLE FABRIC, WHICH SHE DID NOT USE. AFTER AN UNSPECIFIED DURATION, WHILE ON HER WAY HOME, SHE REALIZED SHE WAS HAVING AN ANAPHYLACTIC REACTION SINCE HER THROAT WAS CLOSING, HER HEART WAS RACING AND SHE HAD TROUBLE BREATHING. BY THE TIME SHE GOT HOME, SHE EXPERIENCED SEVERE RESPIRATORY DISTRESS. ON THE SAME DAY, SHE REMOVED THE BANDAGE, WASHED HER THUMB AND TOOK BENADRYL (DIPHENYDRAMINE) ORALLY TO TREAT THE EVENTS. SHE DID NOT CONSULT WITH A HEALTHCARE PROVIDER AND DID NOT USE THE DEVICE FURTHER. SHE ALSO REPORTED THAT SHE WOULD EXPERIENCE SIMILAR EVENTS WHENEVER SHE USED PRODUCTS CONTAINING PETROLEUM, LIKE VASELINE AND WITH WHITE POTATOES WHEREIN SHE WOULD DEVELOP AN ANAPHYLACTIC SHOCK WITHIN 30 MINUTES OF PRODUCT USE. ON THE SAME DAY, AFTER A FEW HOURS, SHE FELT BETTER. THE EVENTS RESOLVED. THE ANALYSIS OF PRODUCT AND COMPLAINT CATEGORY WILL BE MANAGED THROUGH MONTHLY TRENDING PROCESS. COMPLAINT TRENDS WILL CONTINUE TO BE MONITORED. THIS REPORT WAS ASSESSED AS SERIOUS (REQUIRED INTERVENTION) AND THE COMPANY CAUSALITY WAS ASSESSED AS RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684580 BAND-AID BRAND AHESIVE BANDAGES FLEXIBLE FABRIC ADHESIVE BANDAGE KGX BRAZIL CONSUMER 8137004431 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention