BEUDAMED
    FDA Adverse Event Death Summary report: N

    3M BRAND TEGADERM BRAND DRESSING

    MDR report key: 291037 · Received August 17, 2000

    Report

    Report Number
    2110898-2000-00012
    Event Type
    Death
    Date Received
    August 17, 2000
    Date of Event
    July 30, 2000
    Manufacturer
    3M COMPANY/3M BROOKINGS PLANT
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ALLEGED INCIDENT INVOLVED THE DEATH OF A PREMATURE INFANT (24 WEEKS GESTATION AT BIRTH). THE HOSP HAD INSERTED TWO UMBILICAL LINES, ONE UMBILICAL ARTERIAL CATHETER AND ONE UMBILICAL VENOUS CATHETER. A 1622 TEGADERM DRESSING WAS APPLIED OVER THE LINES. ONE DAY AFTER LINE INSERTIONS AND APPLICATION OF TEGADERM DRESSING, THE LINES WERE NOT WORKING AND THE DRESSING AND CATHETERS WERE REMOVED. THE AREA AROUND THE UMBILICUS AND UNDER THE DRESSING WAS RED (THE REPORTING INFECTION CONTROL NURSE DID NOT DESCRIBE THIS AS AN ALLERGIC REACTION). THIS AREA LATER INCREASED IN SIZE. THE HOSP TOOK THE NEONATE TO SURGERY AND ATTEMPTED TO EXCISE THE AREA. CULTURES FROM THE AREA EXCISED REVEALED ASPERGILLUS FUMIGATUS. THE INFANT LATER DIED FROM THE ASPERGILLUS FUMIGATUS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M BRAND TEGADERM BRAND DRESSING WOUND DRESSING FRO 3M COMPANY/3M BROOKINGS PLANT NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death