BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCARAWAY SILICONE SCAR GEL

    MDR report key: 17663719 · Received August 31, 2023

    Report

    Report Number
    3019867040-2023-00002
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    June 20, 2023
    Report Date
    August 31, 2023
    Manufacturer
    ALLIANCE PHARMA INC.
    Product Code
    MDA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUBMISSION WAS DELAYED DUE TO DIFFUCULTIES WITH IT SET UP. ALLIANCE PHARMA HAS COMMUNICATED WITH THE FDA ABOUT THIS ISSUE ((B)(6) 2023 ) AND WAS ADVISED TO MAKE A NOTE ON THE DELAY IN SECTION H OF THIS FORM.

    Description of Event or Problem · 0

    CONSUMER CONTACTED CUSTOMER SERVICE ON (B)(6) 2023 ASKING ABOUT COURSE OF ACTION AFTER SCARAWAY GEL ACCIDENTALLY GOT INTO HER EYE. CONSUMER APPLIED SCARAWAY GEL BENEATH HER EYEBROW, AND OVERNIGHT SOME OF THE GEL GOT INTO HER EYE. CONSUMER RINSED THE PRODUCT BUT STATES HER VISION WAS SLIGHTLY BLURRY/IMPAIRED. CONSUMER WAS DIRECTED TO SEEK MEDICAL ADVICE FROM A HEALTH CARE PROFESSIONAL. MULTIPLE FOLLOW UP ATTEMPTS WERE MADE, AND PER RESPONSE EMAIL FROM CONSUMER ON 7/19/23, THE CONSUMER ADVISED THAT SHE DID SEE A HEALTH CARE PROVIDER AND WAS GIVEN EYE DROPS, WHICH RELIEVED HER SYMPTOMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1389235 SCARAWAY SILICONE SCAR GEL SCARAWAY GEL MDA ALLIANCE PHARMA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other