BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRONTOSAN SOLUTION ROUND BOT."NORD"350ML

    MDR report key: 3844671 · Received May 19, 2014

    Report

    Report Number
    2523676-2014-00183
    Event Type
    Other
    Date Received
    May 19, 2014
    Report Date
    January 17, 2014
    Manufacturer
    B. BRAUN MEDICAL AG
    Product Code
    FRO
    PMA / PMN Number
    K072876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B.BRAUN MEDICAL IS REPORTING THIS BECAUSE THE REPORTED CATALOG NUMBER IS PART OF THE PRONTOSAN WOUND IRRIGATION SOLUTION PRODUCT LINE. THE MANUFACTURER'S REPORT HAS BEEN IDENTIFIED AS 3007120504-2014-00014. PER THE MANUFACTURER, THE INSTRUCTIONS FOR USE OF THE PRODUCT HAVE 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 ((B)(4)), ANAPHYLACTIC SHOCK HAS BEEN REPORTED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOWUP REPORT WILL BE SUBMITTED. WE CONTINUOUSLY MONITOR PRODUCT INCIDENT REPORTS TO IDENTIFY TRENDS WHICH MIGHT AFFECT THE QUALITY OF OUR PRODUCTS. WE WILL MAINTAIN THIS REPORT FOR FUTURE REFERENCE, AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR NATURE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: PATIENT HAD AN ALLERGIC REACTION TO PRONTOSAN WOUND IRRIGATION SOLUTION. GOT AN IMMINENT REACTION WITH URTICARIA AND BLISTERS ON THE BODY. NO INFLUENCE OF RESPIRATION OR CIRCULATION. WAS TREATED WITH ANTIHISTAMINE AND STEROIDS. THE PATIENT WAS DISCHARGED THE SAME DAY. THE WOUND WAS ON HIS STOMACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295835 PRONTOSAN SOLUTION ROUND BOT."NORD"350ML WOUND IRRIGATION SOLUTION FRO B. BRAUN MEDICAL AG NA 13133M04

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R