BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFEVAC

    MDR report key: 15043658 · Received July 15, 2022

    Report

    Report Number
    MW5110917
    Event Type
    Injury
    Date Received
    July 15, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 13, 2022
    Manufacturer
    LIFEVAC, LLC
    Product Code
    GCX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THIS CONCERNS A DEVICE CALLED THE LIFEVAC, MANUFACTURED AND MARKETED BY: LIFEVAC, LLC (B)(4). FROM THIS PAGE ON THE COMPANY'S WEBSITE DATED YESTERDAY HTTPS://BITYL.CO/DE6W, IT WAS REPORTED TO US THAT ON (B)(6) 2022, A 9-YEAR-OLD BOY CHOKED ON A LOLLIPOP (FLAT SUCKER). THE CANDY CAUSED A PARTIAL OBSTRUCTION WHICH TURNED INTO A TOTAL BLOCKAGE. LIFEVAC WAS USED AFTER PROTOCOL FAILED. "SUCKER BROKE DUE TO THE SUCTION OF THE LIFEVAC AND DISLODGED IT INTO PIECES" IF THE DEVICE SHATTERED A LOLLIPOP INTO PIECES, THAT COULD POSE THE RISK OF SERIOUS COMPLICATIONS. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333537 LIFEVAC APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX LIFEVAC, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown