BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUREWRAP PEDIATRIC SMALL (CRITICOOL)

    MDR report key: 16768135 · Received April 19, 2023

    Report

    Report Number
    16768135
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    April 7, 2023
    Report Date
    April 14, 2023
    Manufacturer
    BELMONT INSTRUMENT LLC
    Product Code
    DWJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WHEN GOING TO ASSESS THEIR BABY FOR HANDS ON, COOLING BLANKET WAS NOTED TO BE LEAKING AND A PUDDLE WAS FORMED ON WARMER. INFANT IMMEDIATELY CHANGED TO NEW COOLING BLANKET, DRIED, AND STABILIZED. LEAKING BLANKET WAS BAGGED AND SET ASIDE FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520120 CUREWRAP PEDIATRIC SMALL (CRITICOOL) SYSTEM, THERMAL REGULATING DWJ BELMONT INSTRUMENT LLC M201421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown