BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRONTOSAN SOLUTION ROUND BOT."NORD"350ML

    MDR report key: 3844641 · Received May 19, 2014

    Report

    Report Number
    3007120504-2014-00012
    Event Type
    Other
    Date Received
    May 19, 2014
    Report Date
    January 11, 2013
    Manufacturer
    B. BRAUN MEDICAL AG
    Product Code
    FRO
    PMA / PMN Number
    K072876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THERE WAS NO SAMPLE SENT FOR INVESTIGATION. BASED ON BATCH DOCUMENTATION NO DEVIATIONS HAVE OCCURRED DURING THE MANUFACTURING PROCESS. THE CAUSE FOR THIS ADVERSE REACTION IN THIS CASE IS NOT FULLY CLEAR. AN EPICUTANEOUS TEST WAS OFFERED BUT WAS REJECTED BY THE PATIENT. 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: PATIENT TREATED WITH GAUZE SOAKED WITH PRONTOSAN. DURING THIS TREATMENT ITCHING AROUND THE EYES AND WHEN THE PATIENT WENT HOME INCIPIENT SWELLING/EDEMA OF THE THROAT/NECK. THIS FALLS AFTER A FEW DAYS. THE HOMECARE NURSE REPORTED THIS AS AN ADVERSE REACTION. AN EPICUTANEOUS TEST WAS REJECTED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295885 PRONTOSAN SOLUTION ROUND BOT."NORD"350ML WOUND IRRIGATION SOLUTION FRO B. BRAUN MEDICAL AG 400415 12351M08

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other