BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OHMEDA BILIBLANKET PHOTOTHERAPY SYSTEM

    MDR report key: 249755 · Received November 16, 1999

    Report

    Report Number
    1121732-1999-00008
    Event Type
    Injury
    Date Received
    November 16, 1999
    Report Date
    October 22, 1999
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    LBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS BEING TREATED WITH THE BILIBLANKET AND RECEIVED A CUT ON HIS LEG, ALLEGEDLY BECAUSE THERE WAS DRIED ADHESIVE WHERE THE CABLE AND THE PAD ARE HELD TOGETHER. THE CUT WAS TREATED WITH ANTIBIOTIC OINTMENT AND HAS SINCE HEALED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL DETAILS, INCLUDING WHETHER THE PROTECTIVE COVER WAS BEING USED, NO OTHER INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OHMEDA BILIBLANKET PHOTOTHERAPY SYSTEM NEONATAL PHOTOTHERAPY INIT LBI OHMEDA MEDICAL BILIBLANKET PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention