BEUDAMED
    FDA Adverse Event Death Summary report: N

    NU-GEL WOUND DRESSING

    MDR report key: 50124 · Received November 15, 1996

    Report

    Report Number
    1618732-1996-00075
    Event Type
    Death
    Date Received
    November 15, 1996
    Date of Event
    October 17, 1996
    Report Date
    October 18, 1996
    Manufacturer
    JOHNSON & JOHNSON MEDICAL, INC.
    Product Code
    MGQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A TWO YR OLD BOY SUFFERED 1ST AND 2ND DEGREE BURNS TO 65% OF HIS BODY. "ONE OF THE HOSP'S RESIDENTS TOLD CO TO THE PT STAYED AROUND FOUR DAYS IN THE EMERGENCY AREA." THE BOY WAS TRANSFERRED "TO THE INTENSIVE CARE UNIT ON THURSDAY THE 17TH." HE WRITES THAT THE SALES REP WAS REQUESTED, BY A PLASTIC SURGEON, TO COME IN AND GO WITH "THE NURSE ON DUTY TO APPLY THE PRODUCT. ON FRIDAY, THE 18TH HE RECEIVED A CALL FROM THE DR "SAYING THAT PRODUCT WORSEN THE BOY'S CONDITION TO THE EXTEND THAT HE MAY DIE." THEY ALSO ARE ASKING FOR PAYMENT OF THE TREATMENT. THE CHILD DIED ON SATURDAY, 10/19/96.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NU-GEL WOUND DRESSING DRESSING,SURGICAL WOUND MGQ JOHNSON & JOHNSON MEDICAL, INC. NA 50035117

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Death