BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONTOSAN

    MDR report key: 17050020 · Received June 2, 2023

    Report

    Report Number
    3007120504-2023-00003
    Event Type
    Injury
    Date Received
    June 2, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 2, 2023
    Manufacturer
    B. BRAUN MEDICAL AG
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL AG INTERNAL REPORT NUMBER (B)(4). THE INSTRUCTION FOR USE (IFU) OF THE PRODUCT HAS BEEN CHECKED AND THE FOLLOWING SIDE EFFECTS ARE LISTED: "IN VERY RARE CASES, THERE MAY BE A MILD BURNING SENSATION AFTER APPLICATION OF PRONTOSAN®, BUT THIS USUALLY DISSIPATES AFTER A FEW MINUTES. PRONTOSAN® CAN CAUSE ALLERGIC REACTIONS SUCH AS ITCHING (URTICARIA) AND RASHES (EXANTHEMA). IN RARE CASES (LESS THAN 1 OUT OF 10,000), ANAPHYLACTIC SHOCK HAS BEEN REPORTED." THE PRODUCT QUANTITIES SOLD IN 2022 FOR PRONTOSAN SOLUTION WERE OVER (B)(4). THERE IS NO EVIDENCE OF A TREND. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B.BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    AFTER APPLICATION OF PRONTOSAN WOUND IRRIGATION SOLUTION, THE PATIENT (MALE, 60 YEARS OF AGE) COMPLAINED OF BURNING, FOLLOWED BY SEVERE PAIN AND THEN ANAPHYLACTIC SHOCK. BETADINE WAS APPLIED TO THE PATIENT BEFOREHAND. HOWEVER, THE IODINE RINSE WAS NEUTRALISED WITH RINGER'S SOLUTION BEFORE APPLICATION OF PRONTOSAN. PATIENT HAD TO BE TREATED IN THE ICU. HE WAS TRANSFERRED BACK TO THE NORMAL UNIT. THE HEALTHCARE PROFESSIONAL PROVIDED THE FOLLOWING INFORMATION ADDITIONALLY: THE PATIENT HAD FELT A BURNING SENSATION IMMEDIATELY AFTER APPLICATION OF THE PRONTOSAN INTO THE WOUND, WHICH IMMEDIATELY DEVELOPED REDNESS ALL OVER THE BODY. THIS LED TO SHORTNESS OF BREATH IN A SHORT TIME, SO RESUSCITATION WAS IMMINENT. THE PATIENT WAS TRANSFERRED TO ICU. THE WOUND HAS BLED LITTLE AFTER MECHANICAL WOUND CLEANSING, IT IS SUSPECTED THAT THE ACTIVE INGREDIENT HAS ENTERED THE BLOODSTREAM. THE WOUND WAS ALREADY BANDAGED WITH PRONTOSAN AT HOME, WHERE HE HAD NO PROBLEMS. I CAN'T MAKE ANY STATEMENTS ABOUT THE MEDICATION ON THE ICU, ONLY THAT HIGH-DOSE CORTISONE WAS ADMINISTERED AND SHORT-TERM VENTILATION WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1648458 PRONTOSAN PRONTOSAN WOUND IRRIGATION SOLUTION FRO B. BRAUN MEDICAL AG 22093M16

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Life Threatening| H| O