BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CADEXOMER IODINE

    MDR report key: 6380040 · Received February 27, 2017

    Report

    Report Number
    MW5068258
    Event Type
    Injury
    Date Received
    February 27, 2017
    Date of Event
    January 4, 2017
    Report Date
    February 19, 2017
    Manufacturer
    UNK
    Product Code
    KOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED DIFFUSE RASH ON CHEST, ABDOMEN, ARMS, BACK, AND MID THIGHS. NO OTHER SYMPTOMS OBSERVED DURING HOSPITAL ADMISSION FOR RIGHT FOOT LESION. PT WAS RECEIVING SEVERAL MEDICATIONS, INCLUDING ANTIBIOTICS, WHICH MAY HAVE ALSO CONTRIBUTED TO THE HYPERSENSITIVITY REACTION. CADEXOMER IODINE AS WELL AS VANCOMYCIN AND ZOSYN WERE DISCONTINUED UPON OBSERVATION OF THE RASH. PATIENT RECEIVED A DOSE OF DIPHENHYDRAMINE. RASH GRADUALLY IMPROVED OVER THE NEXT 2-3 DAYS. SYMPTOMS: RASH. DATES OF USE: (B)(6) 2016 THRU (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142344 CADEXOMER IODINE IODOSORB KOZ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR DIPHENHYDRAMINE, ROUTE: IV.