BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSTORP OINTMENT 40

    MDR report key: 5728973 · Received June 16, 2016

    Report

    Report Number
    8043484-2016-00068
    Event Type
    Injury
    Date Received
    June 16, 2016
    Report Date
    June 15, 2016
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KOZ
    PMA / PMN Number
    K905069
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUFFERED DISCOLORATION TO THE SKIN IN THE HIP AREA AFTER BEING TREATED WITH IODOSORB. IT WAS ALLEGED THAT IODOSOB DRIPPED ONTO, AND STAINED, THE SKIN. IT IS BROWN IN COLOR AND IS NTO FADING DESPITE ATTEMPTS TO RESOLVE THE SITUATION BY THE HCP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385586 PERSTORP OINTMENT 40 BEADS, HYDROPHILIC, FOR WOUND EXUDATE ABSORPTION KOZ SMITH & NEPHEW MEDICAL LTD. 6602125040 BYJ271

    Patients

    Seq Age Sex Outcome Treatment
    1 Other