BEUDAMED
    FDA Adverse Event Other Summary report: N

    BILIBLANKET PLUS

    MDR report key: 103013 · Received July 1, 1997

    Report

    Report Number
    MW1011627
    Event Type
    Other
    Date Received
    July 1, 1997
    Date of Event
    June 2, 1997
    Report Date
    July 1, 1997
    Manufacturer
    OHMEDA MEDICAL
    Product Code
    MEA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 7/1/97 RPTR RECEIVED REPORT RESULTS ON A BILIBLANKET WHICH A FATHER STATES BURNED SON. HOME HEALTH NURSE, PICKED UP PHOTOTHERAPY UNIT. FATHER TOLD HER THAT HIS SON HAD BEEN BURNED. 5/31/97 FATHER NOTICED INFANT'S BACK WAS RED WHEN CHILD WAS PICKED UP. PARENTS TOOK CHILD TO A PEDIATRICIAN. DR. ADVISED REDNESS ON BACK WAS LIKE THAT OF A MILD SUNBURN. 6/2/97 NURSE WENT TO GET UNIT. FATHER HAD CONTINUED TO USE UNIT AFTER NOTING REDNESS AND DID NOT NOTIFY AGENCY UNTIL 6/2/97. FATHER DID NOT LET HOME HEALTH NURSE LOOK AT BURN ON INFANT. HE DID NOT WANT CHILD DISTURBED. IF SHOULD BE NOTED MFR ADVISES INFANT SHOULD BE ROTATED EVERY 2 HOURS. IT CANNOT BE DETERMINED, AT THIS TIME, IF INFANT WAS LEFT ON BACK FOR A PROLONGED TIME PERIOD OR NOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIBLANKET PLUS PHOTOTHERAPY SYSTEM MEA OHMEDA MEDICAL 6600-0533-801 *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DAY Other