BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED SYSTEMS ELECTRO FLO 5000 PERCUSSOR, 30 POWER/FREQUENCY SETTINGS AN

    MDR report key: 7901907 · Received September 21, 2018

    Report

    Report Number
    MW5080064
    Event Type
    Injury
    Date Received
    September 21, 2018
    Date of Event
    September 17, 2018
    Report Date
    September 20, 2018
    Manufacturer
    MED SYSTEM, INC.
    Product Code
    BYI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    REASON FOR REPORT: INITIAL HOSPITALIZATION WHILE ENROLLED IN A CLINICAL TRIAL. PARTICIPANT WAS IN A PHASE 4 OBSERVATIONAL STUDY ((B)(6)) FOR THE EFFICACY, WITHIN FDA INDICATIONS, OF MED SYSTEMS ELECTRO FLO 5000 (K031876). PARTICIPANT HAD BEEN USING THE PHYSICIAN PRESCRIBED DEVICE IN AN INDICATED FASHION FOR APPROX 2 WEEKS PRIOR TO HOSPITALIZATION ON A DAILY BASIS. AT 22:02 EST ON (B)(6) 2018, PARTICIPANT SELF REPORTED GOING TO THE HOSP AND SENDING A MESSAGE TO PI VIA SECURE EMAIL (HIPAA SECURE 45 CFR PART 164 AND 21 CFR PART 11 COMPLAINT) STATING: "I GOT SICK WITH A VIRUS OR SOMETHING OVER THE WEEKEND, WAS ADMITTED TO (B)(6) HOSP TONIGHT." PARTICIPANT WAS CONTACTED AT 12:48 PM EST ON (B)(6) 2018 ABOUT THE EVENT AND ASKED TO CONSULT WITH PRESCRIBING PHYSICIAN ON THE CONTINUED USE OF THE ELECTRO FLO 5000 AND WAS INFORMED THAT ALL STUDY DATA COLLECTION SHOULD BE STOPPED UNTIL THE PRESCRIBING PHYSICIAN AND PARTICIPANT DISCUSSED THE EVENT AND IF HE SHOULD CONTINUE AT A LATER TIME. PARTICIPANT IS STILL IN PROCESSION OF THE ELECTRO FLO 5000 AT THE HOSP, BUT INFORMED CLINICAL TRIAL SPONSOR AND PI ABOUT RETURNING DEVICE AT A LATER DATE AFTER BEING CLEARED BY THIS ATTENDING PHYSICIAN. DOSE OR AMOUNT: 1 AN, FREQUENCY: DAILY, ROUTE: DEVICE MAKES CONTACT WITH EPIDERMIS. DATES OF USE: (B)(6) 2018 - (B)(6) 2018. DIAGNOSIS OR REASON FOR USE: ASSIST IN AIRWAY CLEARANCE THERAPY/PROMOTE AIRWAY CLEARANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738403 MED SYSTEMS ELECTRO FLO 5000 PERCUSSOR, 30 POWER/FREQUENCY SETTINGS AN ELECTRO FLO PERCUSSOR 5000 BYI MED SYSTEM, INC. ELECTRO FLO 5000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization