BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSTORP OINTMENT 40

    MDR report key: 5387959 · Received January 25, 2016

    Report

    Report Number
    8043484-2016-00006
    Event Type
    Injury
    Date Received
    January 25, 2016
    Date of Event
    January 1, 1901
    Report Date
    December 28, 2015
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULT AS NO SAMPLE WAS RETURNED WE HAVE BEEN UNABLE TO PERFORM AN EVALUATION OF THE AFFECTED PRODUCT. IN ADDITION, NO BATCH INFORMATION HAS BEEN PROVIDED FOR THIS INCIDENT AND WE HAVE BEEN UNABLE TO PERFORM A REVIEW OF THE ASSOCIATED BATCH MANUFACTURING RECORDS. HOWEVER IT CAN BE CONFIRMED THAT EACH BATCH RELEASED TO MARKET UNDERGOES FULL TESTING AS OUTLINED IN THE FINISHED PRODUCT SPECIFICATION, AND MUST COMPLY WITH ALL THE REQUIREMENTS. IT CAN ALSO BE CONFIRMED THAT THERE HAVE BEEN NO CHANGES TO THE MANUFACTURING PROCESS OR RAW MATERIALS USED THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE INCIDENT HIGHLIGHTED IN THIS COMPLAINT. THE COMPLAINT FILES HAVE BEEN REVIEWED FOR THE PREVIOUS THREE YEARS AND INCIDENTS OF A SIMILAR FAILURE MODE FOR THE IODOSORB PRODUCT RANGE ARE RARE AND THIS INCIDENT IS NOT INDICATIVE OF AN ADVERSE TREND ASSOCIATED WITH THIS TYPE OF FAILURE MODE. CORRECTIVE ACTION BASED UPON THE RESULTS OF THE INVESTIGATION WHICH HAS NOT BEEN ABLE TO IDENTIFY ANY KNOWN PRODUCT QUALITY DEFECT, NO FURTHER ACTION WILL BE TAKEN AT THIS TIME. HOWEVER COMPLAINTS OF A SIMILAR NATURE WILL BE CLOSELY MONITORED FOR ANY ADVERSE TRENDS AND FURTHER ACTION MAY BE CONSIDERED IN THE FUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS RECEIVE LOCAL WOUND CARE WITH CADEXOMER IODINE OINTMENT. THERE WAS SIGNIFICANT ELEVATION IN PATIENTS' SERUM AND URINE IODINE LEVEL. PATIENT WAS STARTED ON METHIMAZOLE AND CARDIZEM. HE CONVERTED BACK TO NORMAL SINUS RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45985 PERSTORP OINTMENT 40 IODOSORB 40G KOZ SMITH & NEPHEW MEDICAL LTD. GB6602125040

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR