BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONTOSAN LOESUNG RUNDFL.OTC"WEST" 350ML

    MDR report key: 5320063 · Received December 22, 2015

    Report

    Report Number
    3007120504-2015-00644
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    November 13, 2015
    Report Date
    November 23, 2015
    Manufacturer
    B. BRAUN MEDICAL AG
    Product Code
    FRO
    PMA / PMN Number
    K072876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLES SENT FOR ANALYTICAL INVESTIGATION SHOWED NO PRODUCT FAILURE. FURTHER TESTS REGARDING PRONTOSAN (POLYHEXANIDE) WILL BE PERFORMED BY THE HOSPITAL. HOWEVER, NO INFORMATION ABOUT THE OUTCOME OF POLYHEXANIDE TESTING WILL BE FORWARDED TO B. BRAUN MEDICAL (B)(4). A REVIEW OF THE BATCH HISTORY RECORDS FOR THE REPORTED BATCH NUMBER REVEALED NO NON-CONFORMANCES OR DEVIATIONS WERE FOUND DURING IN PROCESS OR FINAL INSPECTIONS. 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 PRODUCTION QUANTITIES IN 2014 FOR PRONTOSAN WOUND IRRIGATION SOLUTION WERE OVER (B)(4). NO NEGATIVE TREND CAN BE OBSERVED. 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. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: PATIENT (MALE, 1972), SUFFERING FROM POLY-ARTHRITIS AND PSORIASIS HAD A WOUND CARE AFTER FISTULECTOMY OF A PERIANAL FISTULA WITH PRONTOSAN WOUND IRRIGATION SOLUTION. AFTER THE RINSING THE WOUND BED WITH 0.9% NACL PRONTOSAN WOUND IRRIGATION SOLUTION WAS USED. THE SOLUTION WAS ADMINISTERED WITH AN IRRIGATION CANNULA WHICH IS PUT ON THE TOP OF A SYRINGE. WITH THIS APPLICATION, THE SOLUTION CAN BE APPLIED ON THE WOUND WITHOUT PRESSURE. THIS RINSING PROCESS WAS REPEATED SEVERAL TIMES. AFTER TEN MINUTES OF TREATMENT, THE PATIENT HAD TO SNEEZE SEVERAL TIMES (12 TIMES). HE WAS FEELING VERY BAD, WAS TREMBLING AND WAS UNRESPONSIVE. THE EMERGENCY WAS CONTACTED IMMEDIATELY AND THE PATIENT NEEDED CARDIOPULMONARY RESUSCITATION. PATIENT WAS IN COMA FOR TWO DAYS. ACCORDING TO THE PHYSICIAN, THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL. PATIENT WAS TESTED POSITIVE FOR CHLORHEXIDINE. POLYHEXANIDE, IN CONTRAST TO CHLORHEXIDINE, DOES NOT CONTAIN CHLOROBENZENE AS DERIVATE. HOWEVER, BOTH SUBSTANCES POLYHEXANIDE AND CHLORHEXIDINE BELONG TO THE FAMILY OF BIGUANIDES AND SHARE SIMILARITIES CONCERNING THE CHEMICAL FORMULA. THEREFORE, IT IS SUGGESTED, THAT THE PATIENT MIGHT ALSO BE POSITIVE TESTED FOR POLYHEXANIDE. APART FROM THAT, NO OTHER ALLERGIES OR CONCOMITANT DISEASES ARE KNOWN. PATIENT WILL BE TESTED FOR PRONTOSAN (POLIHEXANIDE). HOWEVER, NO INFORMATION ABOUT THE OUTCOME OF POLIHEXANIDE TESTING WILL BE FORWARDED TO B. BRAUN MEDICAL (B)(4). SAMPLES WERE ANALYZED AT THE SITE OF B.BRAUN MEDICAL (B)(4). ALL TESTED PARAMETERS WERE WITHIN THE SPECIFICATION. THEREFORE, PRODUCT FAILURE IS EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844226 PRONTOSAN LOESUNG RUNDFL.OTC"WEST" 350ML WOUND IRRIGATION SOLUTION FRO B. BRAUN MEDICAL AG 15043M04

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R