BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGVENTURE MAGPROXP

    MDR report key: 8232995 · Received January 4, 2019

    Report

    Report Number
    8232995
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    December 31, 2018
    Report Date
    January 4, 2019
    Manufacturer
    MAGVENTURE INC.
    Product Code
    GWF
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SUBJECT WAS PROVIDED WITH (B)(6) STUDY TREATMENT (ECT/MST) AS USUAL. TREATMENT WAS PROVIDED WITH NO ISSUES. HOWEVER, UPON RECOVERY THE SUBJECT DEVELOPED BRONCHOSPASM AND EPISODIC COUGH WHICH CAUSED A DESATURATION IN OXYGEN LEVELS AND INCREASED PULSE RATE. SAE DEEMED TO BE RELATED TO STUDY PROCEDURES BUT NOT DIRECTLY TO TREATMENT DEVICE. THE TREATING PHYSICIAN DEEMS THIS REACTION TO BE RELATED TO THE ANESTHETIC AGENTS USED IN THE PROTOCOL AND IS IN NO WAY RELATED TO THE DEVICE. ASSOCIATED PROTOCOL IDE# (B)(4) ((B)(6)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9781 MAGVENTURE MAGPROXP NONE GWF MAGVENTURE INC. 9016A0511

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization BREO (FLUTICASONE FUROATE AND VILANTEROL) DAILY 1 PUFF| FLUOXETINE 20MG