BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABREVA CONCEAL

    MDR report key: 3032584 · Received April 1, 2013

    Report

    Report Number
    3008395004-2013-00001
    Event Type
    Other
    Date Received
    April 1, 2013
    Report Date
    March 29, 2013
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 3008395004-2013-00001. ABREVA CONCEAL IS MANUFACTURED AT BIOFARM (B)(4). THE LOT NUMBER FOR THIS PRODUCT IS AVAILABLE; HOWEVER IT IS UNKNOWN WHETHER THE PRODUCT WILL BE RETURNED FOR QUALITY ASSURANCE TESTING. (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER AND DESCRIBED THE OCCURRENCE OF EXACERBATION OF COLD SORES IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO RECEIVED CLASS 1 MEDICAL DEVICE (ABREVA CONCEAL) FOR AN UNKNOWN DRUG INDICATION. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. ON AN UNKNOWN DATE, THE PATIENT STARTED CLASS 1 MEDICAL DEVICE. AT AN UNKNOWN TIME AFTER STARTING CLASS 1 MEDICAL DEVICE, THE PATIENT EXPERIENCED EXACERBATION OF COLD SORES, CONDITION AGGRAVATED, APPLICATION SITE SCAB, COLD SORE BLEEDING, SCAB FELL OFF AT APPLICATION SITE, YELLOW PUS AT APPLICATION SITE, MOIST COLD SORE AND PRODUCT COMPLAINT. THIS CASE WAS ASSESSED AS MEDICALLY SERIOUS BY GSK. TREATMENT WITH CLASS 1 MEDICAL DEVICE WAS DISCONTINUED. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS UNKNOWN. CALLER REPORTED CONDITION AGGRAVATED FURTHER DESCRIBED AS THIS MADE MY COLD SORE WORSE. CALLER FURTHER DESCRIBED CONDITION AGGRAVATED AS MY COLD SORE WAS DRYING BEFORE I USED THE PATCHES AND WHEN I WOKE THE COLD SORE WAS WET AND THE SCAB THAT HAD BEEN FORMING WAS THEN COVERED IN PUS. CALLER ALSO REPORTED THAT IN REMOVING THE PATCH FROM HER COLD SORE THE SCAB WAS REMOVED FROM THE COLD SORE AND THE COLD SORE THEN BLED LESS THAN A TABLESPOON. CALLER REPORTED THESE EVENTS HAVE RESOLVED, AND THE COLD SORE IS NOW DRYING AGAIN. COLD SORE IS NOT YET COMPLETELY HEALED. CALLER ALSO REPORTED PRODUCT COMPLAINT OF ADHESION. SHE SAID TWO OF THE ABREVA CONCEAL WOULD NOT STAY ON HER LIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133819 ABREVA CONCEAL CLASS 1 MEDICAL DEVICE KGX GLAXOSMITHKLINE NA 14512I2C

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other