BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONTOSAN WOUND GEL FLASCHE "WEST" 30ML

    MDR report key: 4201842 · Received October 20, 2014

    Report

    Report Number
    3007120504-2014-00379
    Event Type
    Injury
    Date Received
    October 20, 2014
    Report Date
    October 7, 2014
    Manufacturer
    B. BRAUN MEDICAL AG
    Product Code
    FRO
    PMA / PMN Number
    K072876
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B. BRAUN MEDICAL IS REPORT THIS BECAUSE THE REPORTED CATALOG NUMBER IS PART OF THE PRONTOSAN WOUND IRRIGATION SOLUTION PRODUCT LINE. THE CASE WAS DETECTED DURING ROUTINE LITERATURE RESEARCH. 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. (B)(4).

    Description of Event or Problem · 1

    CASE REPORT PUBLISHED: A (B)(6) WOMAN HAD A SUDDEN EPISODE OF MALAISE, GENERALIZED SKIN ITCHING, RASH, DYSPNEA, PERIPHERAL CYANOSIS AND CARDIO-RESPIRATORY ARREST AFTER WOUND CARE OF AN ULCER IN THE FOOT WITH PRONTOSAN WOUND GEL (UNDECYLENAMIDOPROPHYL BETAINE, POLY HEXANIDE, GLYCEROL, PURIFIED WATER, AND HYDROXYETHYLCELLULOSE), ASKINA (MODIFIED STARCH POLYMER, GLYCEROL AND WATER) AND IRUXOL MONO (CLOSTRIDIOPEPTIDASES). SHE NEEDED CARDIOPULMONARY RESUSCITATION AND ADMISSION TO ICU (INTENSIVE CARE UNIT). TWO-THREE DAYS LATER SHE AGAIN PRESENTED A SIMILAR EPISODE WITH THE SAME FOLLOW-UP, WHILE THE FOOT ULCER WAS BEING TREATED WITH PRONTOSAN AND IRUXOL MONO. THE PATIENT HAD NO KNOWN HISTORY OF ALLERGY. SHE TAKES TREATMENT FOR UNDERLYING DISEASE (HEART DISEASE, LOWER LIMB ISCHEMIA, HYPOTHYROIDISM, AND DIABETES) WITH GOOD TOLERANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667100 PRONTOSAN WOUND GEL FLASCHE "WEST" 30ML WOUND GEL FRO B. BRAUN MEDICAL AG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| L| R DIABETES| DISEASE, LOWER LIMB ISCHEMIA, HYPOTHYROIDISM, AND | SHE TAKES TREATMENT FOR UNDERLYING DISEASE: HEART| DIABETES| DISEASE, LOWER LIMB ISCHEMIA, HYPOTHYROIDISM, AND| SHE TAKES TREATMENT FOR UNDERLYING DISEASE: HEART