BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUSHION FACE MASK

    MDR report key: 6169227 · Received December 8, 2016

    Report

    Report Number
    MW5066649
    Event Type
    Injury
    Date Received
    December 8, 2016
    Date of Event
    December 7, 2016
    Report Date
    December 8, 2016
    Manufacturer
    WILLY RUSCH
    Product Code
    BYG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE CUSHION FACE MASK WAS PULLED OUT OF PACKAGING DURING AN INFANT RESUSCITATION EVENT. ITEM FAILED TO SEAL, WAS DEFLATED. TEAM WENT TO USE ANOTHER CUSHION FACE MASK, THE PRODUCT FAILED TO SEAL AROUND THE HYPERINFLATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807425 CUSHION FACE MASK CUSHION FACE MASK BYG WILLY RUSCH 158100 1160613042

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Required Intervention