BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRONTOSAN SOLUTION ROUND BOT. "WEST" 350ML

    MDR report key: 3844685 · Received May 19, 2014

    Report

    Report Number
    3007120504-2014-00013
    Event Type
    Other
    Date Received
    May 19, 2014
    Date of Event
    October 9, 2012
    Report Date
    October 9, 2012
    Manufacturer
    B. BRAUN MEDICAL AG
    Product Code
    FRO
    PMA / PMN Number
    K072876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INSTRUCTIONS FOR USE OF THE PRODUCT HAVE BEEN CHECKED AND THE FOLLOWING GENERAL SAFETY INSTRUCTIONS ARE LISTED AMONGST OTHERS: FOR EXTERNAL USE ONLY. DO NOT USE FOR INFUSION OR INJECTION. THE CASE REPRESENTS AN OBVIOUS MISUSE, WHICH NEEDED MEDICAL INTERVENTION TO PREVENT POTENTIAL DAMAGE TO THE SKIN ON THE FOREHEAD. 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: THE DOCTOR RECOGNIZED THAT WAS A CONFUSION/MISTAKE, BECAUSE SHE DILUTED THE BOTOX WITH PRONTOSAN INSTEAD OF NACL, SUBCUTANEOUSLY INJECTED LESS THAN 0,5 ML IN 4 POINTS ON THE FOREHEAD OF THE PATIENT. WHEALS APPEARED, ON THE FOREHEAD. THE DOCTOR IS VERY WORRIED, THINKING ABOUT THE POSSIBILITY THAT THE SKIN MAY BECOME NECROTIC. THE DOCTOR TREATED THE PATIENT WITH TOPICAL CORTICOSTEROIDS (LOCAL). EVOLUTION: (B)(6) 2012: THE WHEALS SEEM TO HAVE GONE DOWN, REABSORB. THE DOCTOR RECOGNIZED THAT THERE WAS A CONFUSION/MISTAKE, BECAUSE THE BOTOX WAS DILUTED WITH PRONTOSAN INSTEAD OF NACL. IT'S AN OBVIOUS MISUSE. ON (B)(6) 2012: THE PATIENT RECOVERED. ON (B)(6) 2012: THE DOCTOR INFORMS, THAT THERE WASN'T AN INFLAMMATORY REACTION (REDDENING), BUT THE PAIN WAS REALLY INTENSE AND THE TOTAL REABSORBTION OF THE WHEALS WAS SLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296447 PRONTOSAN SOLUTION ROUND BOT. "WEST" 350ML WOUND IRRIGATION SOLUTION FRO B. BRAUN MEDICAL AG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention BOTOX