BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRONTOSAN SOLUTION ROUND BOT. "WEST" 350ML

    MDR report key: 3844686 · Received May 19, 2014

    Report

    Report Number
    3007120504-2014-00006
    Event Type
    Other
    Date Received
    May 19, 2014
    Date of Event
    July 19, 2010
    Report Date
    July 19, 2010
    Manufacturer
    B. BRAUN MEDICAL AG
    Product Code
    FRO
    PMA / PMN Number
    K072876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 (LESS THAN 1 OUT OF 10,000), ANAPHYLACTIC SHOCK HAS BEEN REPORTED. THE APPLIED PRONTOSAN WOUND IRRIGATION SOLUTION WAS INVESTIGATED AND NO NON-CONFORMITIES COULD HAVE BEEN DETECTED. THE PRODUCT WAS IN COMPLIANCE WITH ITS SPECIFICATIONS. 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: A FEMALE PATIENT WITH HISTORY OF LONG-STANDING DEEP GROIN WOUND FOR WHICH SHE IS BEING TREATED IN A HOMECARE, WAS ADMITTED TO THE HOSPITAL BECAUSE OF PURULENT WOUND DISCHARGE. PRONTOSAN WOUND IRRIGATION SOLUTION WAS APPLIED TO THE WOUND, HOWEVER, WITHIN 10 SECONDS THE PATIENT BECAME UNWELL AND SHOWED FLUSHING OF THE FACE. AFTER ADMINISTRATION OF TAVEGYL (ANTIHISTAMINICUM) IMMEDIATE RECOVERY OCCURRED. THERE WAS NO EVIDENCE OF SEVER SYSTEMIC EFFECTS SUCH AS SHORTNESS OF BREATH, DYSRHYTHMIA OR LOSS OF CONSCIOUSNESS, THUS THE REACTION CAN BE CLASSIFIED AS A MILD ANAPHYLACTIC REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295840 PRONTOSAN SOLUTION ROUND BOT. "WEST" 350ML WOUND IRRIGATION SOLUTION FRO B. BRAUN MEDICAL AG NA 0045M31

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other