BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NONE

    MDR report key: 2232205 · Received August 26, 2011

    Report

    Report Number
    MW5021921
    Event Type
    Injury
    Date Received
    August 26, 2011
    Report Date
    August 26, 2011
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MASTISOL WAS USED TO CLOSE SURGICAL WOUND ORIGINALLY IN (B)(6). ALLERGIC REACTION NOTED AT THAT TIME. SECOND SURGERY WAS PERFORMED ON (B)(6) 2011 AT (B)(6). PATCH TEST WAS PERFORMED AND WAS POSITIVE. REPORTED TO MD AND HOSP AND PRODUCT WAS STILL USED. EXTENDED HOSP STAY WAS REQUIRED, MEDROL DOSE PACK, BENADRYL AND CLEANSING OF THE AREA. PT ALSO DEVELOPED A SORE ITCHING RASH AT SITE, BLISTERS, ITCHING OVER THE ENTIRE BODY. WEAKNESS, DIZZY, NAUSEA AND VOMITING, FATIGUE, SOB, SUFFOCATION TYPE FEELING, AND CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE KGX

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O