BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRONTOSAN SOLUTION ROUND BOT."NORD"350ML

    MDR report key: 3844642 · Received May 19, 2014

    Report

    Report Number
    2523676-2014-00181
    Event Type
    Other
    Date Received
    May 19, 2014
    Report Date
    April 25, 2012
    Manufacturer
    B. BRAUN MEDICAL AG
    Product Code
    FRO
    PMA / PMN Number
    K072876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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. PER THE MANUFACTURER, THEIR REPORT HAS BEEN IDENTIFIED AS 3007120504-2014-00011. 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. THERE WAS NO SAMPLE SENT FOR INVESTIGATION. THE BATCH NUMBER IS UNKNOWN. NO BATCH DOCUMENTATION REVIEW COULD BE PERFORMED. THIS CASE REPRESENTS A ALLERGIC REACTION FOR WHICH IT IS UNCLEAR IF IT NEEDED MEDICAL INTERVENTION; THERE WERE FIRST SIGNS OF SYSTEMIC CONSEQUENCES (EDEMA, DIFFICULTIES OF BREATHING). IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP 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: A PATIENT HAD AN ALLERGIC REACTION CAUSED BY PRONTOSAN. THE REACTIONS WERE: SWELLING OF FINGERS, FACIAL EDEMA AND DIFFICULTIES OF BREATHING. AT FIRST IT WAS THOUGHT THAT THE REACTION WAS CAUSED BY XYLOCAIN, BUT AFTER AN INVESTIGATION BY THE ALLERGIST IT WAS FOUND THAT THE REACTION WAS CAUSED BY PRONTOSAN. THE REASONS FOR THIS CONCLUSION WERE: THE PATIENT HAS SUFFERED SIMILAR ALLERGIC REACTIONS AT THREE TREATMENT SESSIONS WHERE PRONTOSAN HAVE BEEN USED. XYLOCAIN GEL WAS CONCURRENTLY USED AT THE TREATMENT SESSIONS BUT WAS EXCLUDED AS THE CAUSE OF THE ALLERGIC REACTIONS DUE TO A NEGATIVE TEST RESULT ON PRICK / SCRATCH TEST. IN A STANDARD ALLERGY TEST (PRESUMABLY RAST TEST ACCORDING TO THE REPORTER) THE PATIENT TESTED POSITIVE FOR (MILD) ALLERGY TO CATS, NOTHING ELSE. AFTER THE INCIDENTS WITH PRONTOSAN THE PATIENT HAS SAME BANDAGING ETC. BUT WITHOUT PRONTOSAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296286 PRONTOSAN SOLUTION ROUND BOT."NORD"350ML WOUND IRRIGATION SOLUTION FRO B. BRAUN MEDICAL AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other