BEUDAMED
    FDA Adverse Event Other Summary report: N

    IODOSORB GEL

    MDR report key: 19246 · Received August 16, 1994

    Report

    Report Number
    2938996-1994-00001
    Event Type
    Other
    Date Received
    August 16, 1994
    Date of Event
    June 23, 1994
    Report Date
    July 14, 1994
    Manufacturer
    PERSTORP PHARMA
    Product Code
    MGQ
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IODOSORB WAS APPLIED SPARINGGLY TO TWO LEG ULCERS (250MMCM2) BY DR., WITHING 15-20 MINUTES, PT EXPERIENCED GENERALIZED PURURITUS, PERIORBITAL EDEMA AND URTICARA. DR.. PRESCRIBED ANTIHISTIMINE, PT RECOVERED. AT ONE WEEK FOLLOW-UP VISIT, PT MENTIONED TRANSIENT SHORTNESS OF BREATH AT TIME OF ABOVE REACTION. DR. THOUGHT REACTION COULD BE AN ANAPHYLACTIC TYPE RESPONSE TO IODOSORB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IODOSORB GEL WOUND CLEANSING GEL MGQ PERSTORP PHARMA BXC221

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other PERCOCET (1 TAB Q 4 HRS) FOR PAIN RELIEF