BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONTOSAN WOUND IRRIGATION + CAPS US"10X1000ML KCI

    MDR report key: 5520544 · Received March 23, 2016

    Report

    Report Number
    3007120504-2016-00143
    Event Type
    Injury
    Date Received
    March 23, 2016
    Report Date
    March 8, 2016
    Manufacturer
    B. BRAUN MEDICAL AG
    Product Code
    FRO
    PMA / PMN Number
    K072876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2014021. B. BRAUN MEDICAL INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MEDICAL AG(MANUFACTURER). THIS COMPLAINT HAS BEEN IDENTIFIED AS B.BRAUN MEDICAL INTERNAL REPORT #(B)(4) (EVENT 2). IN A FOLLOW UP WITH THE REPORTER, IT WAS CONFIRMED THAT THERE WAS NO HARM TO THE PATIENT. THE INVESTIGATION IS ON GOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2014021. B. BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MEDICAL AG (MANUFACTURER). THE COMPLAINT HAS BEEN IDENTIFIED AS B.BRAUN MEDICAL INTERNAL REPORT NUMBER #(B)(4) (EVENT 1). ALL AVAILABLE INFORMATION WAS FORWARDED TO THE MANUFACTURER FOR FURTHER EVALUATION. PER THEIR RESPONSE, THE DESCRIBED INCIDENCE OF WHITE/YELLOWISH SLOGH FORMATION AFTER USAGE OF PRONTOSAN WOUND IRRIGATION SOLUTION IS KNOWN. TOXICITY STUDY HAS SHOWN THAT MICROSCOPIC EXAMINATION OF THE SLOUGH DEMONSTRATED FIBRIN INCLUDING CELLULAR DEBRIS, WHICH IS A NORMAL COMPONENT OF THE HEALING PROCESS. THEREFORE, NO DETERIORATION IN THE STATE OF HEALTH OR IMPAIRED WOUND HEALING ARE EXPECTED AFTER THE APPEARANCE OF THE WHITE/YELLOWISH SLOUGH. IT W AS COMMUNICATED BY THE REPORTER THAT THERE WERE NO CULTURES BECAUSE THE " DR. DIDN'T SEEM NECESSARY". MULTIPLE ATTEMPTS TO OBTAIN A SAMPLE AND/OR ADDITIONAL INFORMATION WERE NOT SUCCESSFUL. WITHOUT THE ACTUAL SAMPLE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. IF A SAMPLE AND/OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: EVENT #2: I WAS INFORMED TODAY THAT TWO SEPARATE PATIENTS WERE ON PRONTOSAN AT FACILITY (B)(6) FOR ONE WEEK BUT WAS SWITCHED TO VASHE WHEN THE YELLOW FILM WAS FOUND. PATIENTS HAD TO BE TAKEN TO OPERATING ROOM FOR DEBRIDEMENT. NO BIOPSIES WERE TAKEN. VERAFLO CONTINUED. NO HARM TO PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175949 PRONTOSAN WOUND IRRIGATION + CAPS US"10X1000ML KCI WOUND IRRIGATION SOLUTION FRO B. BRAUN MEDICAL AG 14453M03

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR