BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SQUISHON MATTRESS

    MDR report key: 4765080 · Received May 4, 2015

    Report

    Report Number
    4765080
    Event Type
    Malfunction
    Date Received
    May 4, 2015
    Date of Event
    April 24, 2015
    Report Date
    May 4, 2015
    Manufacturer
    CHILDREN'S MEDICAL VENTURES, LLC
    Product Code
    FMP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INFANT TRANSPORT MATTRESS WAS REMOVED FROM WARMER AND HAD COLOR AND COMPOSITION CHANGE. THE ROBERTS VALVE IS VERY EASY TO OPEN. THE MATTRESS HAD STORED IN A WARMER FOR APPROXIMATELY 6 MONTHS.THIS WAS NOTED PRIOR TO PATIENT USE AND TAKEN OUT OF SERVICE.CONTENTS LISTED AS: WATER, NON-TOXIC CARBOXY VINYL AND ANTI-BACTERIAL AGENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292285 SQUISHON MATTRESS MATTRESS SKIN PROTECTOR FMP CHILDREN'S MEDICAL VENTURES, LLC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *