BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECOVER

    MDR report key: 88052 · Received May 2, 1997

    Report

    Report Number
    1025916-1997-00001
    Event Type
    Injury
    Date Received
    May 2, 1997
    Date of Event
    March 12, 1997
    Report Date
    May 2, 1997
    Manufacturer
    FLORIDA MEDICAL INDUSTRIES, INC.
    Product Code
    MPO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE INFANT HEEL WARMER WAS ACTIVATED AND APPLIED TO THE HEEL OF A BABY PRIOR TO A PKU. THE BABY SUSTAINED SECOND DEGREE BURNS ON APPROXIMATELY 40% OF HIS FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECOVER INFANT HEEL WARMER MPO FLORIDA MEDICAL INDUSTRIES, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DAY Hospitalization