BEUDAMED
    FDA Adverse Event Summary report: N

    IODO SORB GEL TUBE 40G

    MDR report key: 9244749 · Received October 25, 2019

    Report

    Report Number
    MW5090687
    Date Received
    October 25, 2019
    Report Date
    October 25, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    KOZ
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    I PREVIOUSLY FILED A REPORT OF LOOK ALIKE PACKAGING WITH IODOSORB AND SANTYL. NOW THERE IS ANOTHER PRODUCT THAT IS USING SIMILAR PACKAGING. THERE HAS NOT YET BEEN AN ERROR TO OUR KNOWLEDGE BUT THE POTENTIAL FOR ERROR IS SIGNIFICANT. SEVERITY: CIRCUMSTANCES OR EVENTS HAVE CAPACITY TO CAUSE ERROR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031855 IODO SORB GEL TUBE 40G BEADS, HYDROPHILIC, FOR WOUND EXUDATE ABSORPTION KOZ SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1