BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONTOSAN WOUND-GEL BOTTLE "NORD" 30ML

    MDR report key: 3833399 · Received May 19, 2014

    Report

    Report Number
    3007120504-2014-00010
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    October 5, 2011
    Report Date
    October 6, 2011
    Manufacturer
    B. BRAUN MEDICAL AG
    Product Code
    FRO
    PMA / PMN Number
    K090141
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EPICUTANEOUS TEST WAS PERFORMED WITH THE RAW SUBSTANCES CONTAINED IN PRONTOSAN SOLUTION AND GEL. THERE WERE NO CLEAR REACTIONS TO ONE OF THE INGREDIENTS. THERE WAS A SLIGHT, AS THE PHYSICIAN SAYS, TOXIC IRRITANT REACTION TO POLIHEXANIDE IN ONE CASE, BUT NO ALLERGIC REACTION. IT IS NOT ENTIRELY CONFIRMED, THAT THE ALLERGIC REACTION WAS CAUSED BY PRONTOSAN SOLUTION OR GEL. EVEN IF THE EPICUTANEOUS TEST DID NOT SHOW A CLEAR POSITIVE RESULT AGAINST ONE OF THE INGREDIENTS OF THE PRONTOSAN PRODUCTS, THE PATIENT HAD A REACTION TO THE APPLICATION OF PRONTOSAN WHICH NECESSITATED MEDICAL INTERVENTION TO PREVENT A FURTHER DETERIORATION OF THE STATE OF HEALTH. 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 REPORTS FOR SIMILAR NATURE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: A (B)(6) LADY, WHO HAD A WOUND ON HER RIGHT LOWER LIMB AFTER FALLING OFF A BICYCLE, THEREBY SCRATCHED HER LEG ON THE ASPHALT, 10X16 CM SUPERFICIAL WOUND. AT FIRST THE WOUND CARE NURSE USED PRONTOSAN ON THIS WOUND, FIRST SOLUTION 400415, BATCH 11078M18 FOR ABOUT 10 MINUTES AND THEN GEL, 400515 BATCH 0485M27. WHEN PRONTOSAN GEL WAS APPLIED, THE PATIENT COMPLAINED THAT SHE WASN'T FEELING VERY WELL. SHE HAD BAGS UNDER THE EYES AND HAD GREAT DIFFICULTY BREATHING. THE DOCTOR CAME RIGHT AWAY, AND SHE WAS TREATED WITH SOLUMEDROL AND TAVEGYL INTRAVENOUS. THE PATIENT WAS DISCHARGED LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295770 PRONTOSAN WOUND-GEL BOTTLE "NORD" 30ML WOUND GEL FRO B. BRAUN MEDICAL AG NA 0485M27

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention