BEUDAMED
    FDA Adverse Event Injury Summary report: N

    270 STABILOCK ET HOLDER

    MDR report key: 14013953 · Received April 5, 2022

    Report

    Report Number
    1214422-2022-00006
    Event Type
    Injury
    Date Received
    April 5, 2022
    Date of Event
    February 10, 2022
    Report Date
    April 5, 2022
    Manufacturer
    DALE MEDICAL PRODUCTS, INC
    Product Code
    CBH
    UDI-DI
    00817612020506
    PMA / PMN Number
    LISTING ONLY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT BEING TREATED USING THE DALE 270 ET TUBE HOLDER DEVELOPED A ROUND WOUND THAT TUNNELS FROM THE INSIDE TO THE OUTSIDE OF HER RIGHT UPPER LIP FROM ET HOLDER. DALE MEDICAL HAS INVESTIGATED THE REPORT INCLUDING INSPECTION AND TESTING OF A DEVICE FROM THE SAME LOT NUMBER 27608 AS THE ONE REPORTED WITH NO ISSUES NOTED. A COMPLETE REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS PRODUCTION LOT 27608 ALSO FOUND NO ISSUES. DALE MEDICAL ALSO PERFORMED INSPECTION AND TESTING AND DHR REVIEW ON OTHER PRODUCTION LOT'S THAT WERE PRODUCED IN THE SAME TIMEFRAME WITH NO ISSUES NOTED. DALE MEDICAL HAS REVIEWED OUR CUSTOMER COMPLAINT FILES AND NOTED THAT WE HAD NO OTHER COMPLAINTS AGAINST THE DALE 270 DEVICE IN THE LAST THREE YEARS; 2019-2021, IN THAT TIME FRAME DALE HAS SHIPPED 500,000 DALE 270 DEVICES WORLDWIDE. THE DALE 270 DEVICE PACKAGING CONTAINS THIS WORDING: DALE RECOMMENDS REPOSITIONING THE ENDOTRACHEAL TUBE OFTEN TO HELP PREVENT INJURY TO THE LIPS AND UNDERLYING TISSUES DUE TO UNRELIEVED PRESSURE. DALE STRONGLY RECOMMENDS SUPPORTING THE VENTILATOR TUBING TO REDUCE PRESSURE ON THE FACE. WE HAVE FOUND THROUGH MANY YEARS OF EXPERIENCE WITH OUR 270 DEVICE THAT WHEN ALL PROVISIONS OF OUR INSTRUCTIONS FOR USE ARE FOLLOWED THERE ARE VERY FEW ISSUES REPORTED. DALE MEDICAL THEREFOR HAS CONCLUDED THAT THERE APPEARS TO BE NO ISSUES WITH THE DEVICE AND THE CAUSE OF THE WOUND COULD BE RELATED TO THE FREQUENCY OF ET TUBE REPOSITIONING.

    Description of Event or Problem · 0

    "PATIENT HAS A ROUND WOUND THAT TUNNELS FROM THE INSIDE TO THE OUTSIDE OF HER RIGHT UPPER LIP FROM ET HOLDER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339426 270 STABILOCK ET HOLDER 270 STABILOCK ET HOLDER CBH DALE MEDICAL PRODUCTS, INC 270 27608 00817612020506

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other