BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONTOSAN SOLUTION ROUND BOT. "WEST" 350ML

    MDR report key: 3833395 · Received May 19, 2014

    Report

    Report Number
    3007120504-2014-00003
    Event Type
    Injury
    Date Received
    May 19, 2014
    Date of Event
    May 9, 2009
    Report Date
    July 15, 2009
    Manufacturer
    B. BRAUN MEDICAL AG
    Product Code
    FRO
    PMA / PMN Number
    K072876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN (B)(4). THERE WERE NO SAMPLE SENT FOR INVESTIGATION. THE CAUSE FOR THIS ADVERSE REACTION IN THIS CASE IS NOT FULLY CLEAR. AN EPICUTANEOUS TEST IN ORDER TO CONFIRM THE POTENTIAL ALLERGY TO ONE OF THE INGREDIENTS OF PRONTOSAN WAS OFFERED TO THE PATIENT BUT WAS REJECTED. 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: ALLERGIC TOXIC REACTION AFTER PRONTOSAN TREATMENT THAT USED FOR WOUND CLEANSING BEFORE SUPRATHEL APPLICATION. PATIENT HAD A GENERAL ANESTHESIA WITH PROPOFOL, RAPIFEN AND DIPIDOLOR AND WAS INTUBATED WITH A LARYNGEAL MASK AIRWAY WITH ATRACURIUM. PATIENT SHOWED AN ABRUPT BRONCHOSPASM, DECREASED OXYGEN SATURATION, LOSS OF BLOOD PRESSURE AND TACHYCARDIA. ERYTHEMA AND WHEAL RESPONSE OCCURRED. PATIENT HAS BURNED 12 % OF ITS BODY SURFACE AREA (BSA) ALLERGIC REACTION MAY ALSO HAVE BEEN OCCURRED DUE TO APPLICATED ANAESTHETICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295608 PRONTOSAN SOLUTION ROUND BOT. "WEST" 350ML WOUND IRRIGATION SOLUTION FRO B. BRAUN MEDICAL AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1.5 YR Life Threatening| O| R INTUBATION WITH ATRACURIUM. (MUSCLE RELAXANT)| PROPOFOL, RAPIFEN AND DIPIDOLOR.| GENERAL ANESTHESIA WITH