BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISAFE INFANT HEEL WARMER

    MDR report key: 4218758 · Received October 30, 2014

    Report

    Report Number
    1216677-2014-00016
    Event Type
    Injury
    Date Received
    October 30, 2014
    Date of Event
    January 2, 2008
    Report Date
    October 29, 2014
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    MPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    E-COMPLAINT #(B)(4). COOPERSURGICAL INC. IS CURRENTLY INVESTIGATING THE REPORTED COMPLAINT CONDITION. A FINAL REPORT WILL BE FILED AFTER CUSTOMER FOLLOW UP AND INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    PATIENT SUFFERED SEVERE BURNS TO HIS HEEL AND CALF AND IT IS ALLEGED THAT BURN OCCURRED AT (B)(6) HOSPITAL. COOPERSURGICAL PRODUCT SURVEILLANCE BECAME AWARE OF THE EVENT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696558 MEDISAFE INFANT HEEL WARMER INFANT HEEL WARMER MPO COOPERSURGICAL, INC. 24648 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other