BEUDAMED
    FDA Adverse Event Death Summary report: N

    MIRRAGEN ADVANCED WOUND MATRIX

    MDR report key: 7781440 · Received August 14, 2018

    Report

    Report Number
    3013542522-2018-00001
    Event Type
    Death
    Date Received
    August 14, 2018
    Date of Event
    July 16, 2018
    Report Date
    August 4, 2018
    Manufacturer
    ETW WOUIND CARE LLC
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLINICIAN, PRINCIPAL INVESTIGATOR, (B)(4) AND MFR HAVE CONCLUDED THAT THIS DEATH IS IN NO WAY RELATED TO THE USAGE OF THE PRODUCT.

    Description of Event or Problem · 1

    A (B)(6) CAUCASIAN MALE WITH A MEDICAL HISTORY OF MITRAL VALVE PROLAPSE, PERMANENT ATRIAL FIBRILLATION, FIRST DEGREE AV BLOCK, CHRONIC CONGESTIVE HEART FAILURE, HYPERTENSION, HYPERLIPIDEMIA, NEUROPATHY, AND TYPE II DIABETES, WAS HOSPITALIZED ON (B)(6) 2018 FOR SHORTNESS OF BREATH. HE WAS FOUND TO SUFFER ACUTE RESPIRATORY FAILURE SECONDARY TO CHF AND PLEURAL EFFUSION. HE UNDERWENT DIURESIS AND IMPROVED. HE WAS DISCHARGED (B)(6) 2018, WITH THE FOLLOWING MEDICATION LIST (ALL OF WHICH WERE HISTORICAL MEDICATIONS): WARFARIN 2.5 MG EVERY OTHER DAY; MAGOX 400 1 TABLET EVERY MORNING; LEVOTHYROXINE 50 MCG TABLET ONE TABLET EVERY MORNING; ESCITALOPRAM 10 MG ONE TABLET EVERY MORNING; OXAZEPAM 10 MG CAPSULE ONE NIGHTLY; CHOLECALCIFEROL 5000 UNITS ONE TABLET EVERY MORNING; COENZYME Q-10 200 MG ONE CAPSULE EVERY MORNING; CYANOCOBALAMIN (VIT B-12 SL) ONE TABLET EVERY MORNING; K-EFFERVESCENT 25 MEQ ONE TABLET TWICE DAILY; LATANOPROST .005% OPHTHALMIC SOLUTION ONE DROP RIGHT EYE NIGHTLY; WARFARIN 5 MG ONE TABLE EVERY OTHER DAY; DORZOLAMIDE-TIMOLOL 22.3-6.8 MG /ML ONE DROP RIGHT EYE TWICE DAILY; BRIMONIDINE 0.1% SOLN ONE DROP RIGHT EYE TWICE DAILY; AMLODIPINE 10 MG ONE TABLET TWICE DAILY; HYDRALAZINE 25 MG ONE TABLET TWICE DAILY; ROSUVASTATIN 5 MG ONE TABLET NIGHTLY; DOCUSATE SODIUM 100 MG ONE CAPSULE EVERY MORNING; AMMONIUM LACTATE 12% LOTION APPLY TOPICALLY TO BILATERAL LEGS WITH DRESSING CHANGES; BUMETANIDE 1 MG ONE TABLET TWICE DAILY; PANTOPRAZOLE 40 MG ONE TABLE EVERY MORNING; CALCIUM CARBONATE 500 MG ONE TABLE EVERY MORNING; METFORMIN 500 MG TWO TABLETS TWICE DAILY; ASPIRIN 81 MG ONE TABLET EVERY MORNING. PATIENT EXPIRED (B)(6) 2018. THE CAUSE OF DEATH - ACUTE ONSET OF CONGESTIVE HEART FAILURE. THE PT WAS ALSO BEING TREATED FOR A DIABETIC FOOT ULCER. TREATMENT INCLUDED THE USE OF THE DEVICE AS A PART OF A POST MARKETING CLINICAL STUDY FOR THE PRODUCT AND WHICH WAS UNDER THE DIRECTION OF A CLINICAL RESEARCH ORGANIZATION ((B)(4)). THE CLINICIAN, PRINCIPAL INVESTIGATOR, (B)(4) AND MFR HAVE CONCLUDED THAT THIS DEATH IS IN NO WAY RELATED TO THE USAGE OF THE PRODUCT. THE MFR IS, HOWEVER, REPORTING THIS INCIDENT TO THE FDA FOR INFO PURPOSES ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623583 MIRRAGEN ADVANCED WOUND MATRIX MIRRAGEN FRO ETW WOUIND CARE LLC 06221703

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death