BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTISOL

    MDR report key: 8343580 · Received February 14, 2019

    Report

    Report Number
    MW5084105
    Event Type
    Injury
    Date Received
    February 14, 2019
    Date of Event
    February 12, 2019
    Report Date
    February 12, 2019
    Manufacturer
    ELOQUEST HEALTHCARE / FERNADALE LABORATORIES, INC
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A LEFT LAPIDUS BUNIONECTOMY ON (B)(6) 2019 AT (B)(6) SURGERY CENTER IN (B)(6). I WAS TOLD ON (B)(6) TO LOOSEN THE BANDAGE AFTER I SOUGHT MEDICAL DEVICE VIA THE NURSELINE AND THAT WOULD HELP WITH THE INTENSE PAIN I FELT. THE PAIN CHANGED IN THE COMING DAYS. OVER THE NEXT WEEK I COULD SEE IT GETTING MORE RED, IRRITATED. ON (B)(6) I REMOVED THE BANDAGE TO LOOK AT WHAT WAS HAPPENING, KNOWING I HAD AN APPOINTMENT AT 4 PM ON (B)(6). THE TOP OF MY FOOT WAS COVERED WITH BURNING, BUBBLING, BLISTERS. ONE HAD BROKEN OPEN AND CONTINUOUSLY OOZED. I CALLED THE DOCTOR ON (B)(6) AND MOVED MY APPOINTMENT TO THEIR EARLIEST AVAILABLE, 1 PM. WITHIN MOMENTS OF THEM UNWRAPPING, THE DOCTOR NOTED THAT I MUST BE ALLERGIC TO THE MASTISOL HE USED TO ADHERE THE ZIPLINE. HE SAID HE HAD SEEN IT 2-3X BEFORE AND THAT IT WAS CLEAR EXACTLY WHERE IT WAS APPLIED WAS WHERE THE BLISTERS WERE. DOCTOR APPLIED TO HELP ADHERE ZIPLINE POST-SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134834 MASTISOL MASTISOL KGX ELOQUEST HEALTHCARE / FERNADALE LABORATORIES, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other