BEUDAMED
    FDA Adverse Event Other Summary report: N

    DALE STABILOCK ENDOTRACHEAL TUBE HOLDER

    MDR report key: 2298256 · Received October 7, 2011

    Report

    Report Number
    1214422-2011-00007
    Event Type
    Other
    Date Received
    October 7, 2011
    Date of Event
    August 17, 2011
    Report Date
    October 7, 2011
    Manufacturer
    DALE MEDICAL PRODUCTS, INC.
    Product Code
    CBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MOTHER OF PT WANTED TO KNOW IF THE DEVICE CONTAINED NEOPRENE AS HER DAUGHTER, THE PT, HAS A KNOWN ALLERGY TO ADHESIVE THAT CONTAIN NEOPRENE. THE MOTHER WAS TOLD THAT THE DEVICE DOES CONTAIN NEOPRENE, A VERY COMMON INGREDIENT IN MEDICAL GRADE ADHESIVES. THE MOTHER SUGGESTED THAT THE DEVICE PACKAGING SHOULD CONTAIN ALL MATERIALS USED IN THE MFR OF THE DEVICE.

    Description of Event or Problem · 1

    MOTHER OF AN INTUBATED PT CALLED TO INQUIRE IF THE DALE 270 ET TUBE HOLDER DEVICE CONTAINED NEOPRENE IN THE ADHESIVE PART OF THE PRODUCT. THE MOTHER REPORTED HER DAUGHTER (THE PT) IS ALLERGIC TO MOST ADHESIVES THAT CONTAIN NEOPRENE AND HER DAUGHTER'S FACE WAS RED IN THE REA OF THE DEVICE AFTER 12 HRS OF APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DALE STABILOCK ENDOTRACHEAL TUBE HOLDER PRODUCT CODE CBH, REG 868,5770 CBH DALE MEDICAL PRODUCTS, INC. 270

    Patients

    Seq Age Sex Outcome Treatment
    1 Other