BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOPER SURGICAL TRANSWARMER INFANT TRANSPORT MATTRESS

    MDR report key: 1190205 · Received October 6, 2008

    Report

    Report Number
    MW5008546
    Event Type
    Injury
    Date Received
    October 6, 2008
    Date of Event
    December 21, 2006
    Report Date
    September 29, 2008
    Manufacturer
    COOPER SURGICAL, INC
    Product Code
    FMT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NEWBORN PREMATURE INFANT TRANSPORTED TO CHILDREN'S FACILITY FROM OUTSIDE HOSP FOR NEONATAL INTENSIVE CARE. INFANT TRANSPORTED ON TRANSWARMER AND ON ARRIVAL, PHYSICIAN NOTED THAT INFANT SUSTAINED BURNS TO RIGHT TORSO AND BILATERAL HEELS SUSPECTED FROM TRANSWARMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOPER SURGICAL TRANSWARMER INFANT TRANSPORT MATTRESS TRANSWARMER MATTRESS FMT COOPER SURGICAL, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R