BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IODOSORB GEL 10G USA CTN 4

    MDR report key: 6636078 · Received June 13, 2017

    Report

    Report Number
    8043484-2017-00163
    Event Type
    Injury
    Date Received
    June 13, 2017
    Date of Event
    May 15, 2017
    Report Date
    October 20, 2017
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KOZ
    PMA / PMN Number
    K905069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED COMPLAINT DEVICES WERE NOT RETURNED FOR EVALUATION. PLEASE SEE ATTACHED FOR INVESTIGATION RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A REACTION TO IODOSORB WITHIN 10MINS OF APPLICATION TO WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416674 IODOSORB GEL 10G USA CTN 4 BEADS, HYDROPHILIC, FOR WOUND EXUDATE ABSORPTION KOZ SMITH & NEPHEW MEDICAL LTD. 66060630

    Patients

    Seq Age Sex Outcome Treatment
    1