BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUREWRAP PEDIATRIC SMALL

    MDR report key: 17324392 · Received July 14, 2023

    Report

    Report Number
    17324392
    Event Type
    Malfunction
    Date Received
    July 14, 2023
    Date of Event
    April 27, 2023
    Report Date
    July 6, 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. RISK CLOSURE COMMENTS: BLANKET REMOVED, NO FURTHER INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179643 CUREWRAP PEDIATRIC SMALL SYSTEM, THERMAL REGULATING DWJ BELMONT INSTRUMENT LLC. M201421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown