BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHORFAST GUARD ORAL ENDOTRACH TUBE FASTENER

    MDR report key: 8667246 · Received June 4, 2019

    Report

    Report Number
    1119193-2019-00021
    Event Type
    Injury
    Date Received
    June 4, 2019
    Date of Event
    April 14, 2018
    Report Date
    June 4, 2019
    Manufacturer
    HOLLISTER INCORPORATED
    Product Code
    CBH
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF POST MARKET SURVEILLANCE DATA RELATING TO THIS REPORTED ISSUE WAS CONDUCTED AND NO TRENDS WERE OBSERVED. DHR REVIEW COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT KNOWN. DEVICE TESTING NOT POSSIBLE BECAUSE THE DEVICE WAS NOT RETURNED TO HOLLISTER FOR EVALUATION. HOLLISTER INCORPORATED REACHED OUT TO THE ACCOUNT CONTACT RELATING TO THE RESEARCH PAPER TO TRY TO OBTAIN FURTHER INFORMATION. NO INFORMATION WAS PROVIDED. HOLLISTER IS UNAWARE IF THE ANCHOR FAST GUARD DEVICE FAILED OR MALFUNCTIONED OR WHAT LEAD TO THE TUBE DISLODGEMENT. THE ACTUAL GENDER, AGE AND WEIGHT OF THE END USER AND DATE OF EVENT WAS NOT PROVIDED SO ESTIMATES WERE USED IN THIS REPORT. THE ROOT CAUSE OF THIS EVENT CANNOT BE DETERMINED. HOLLISTER WILL CONTINUE TO MONITOR THE PERFORMANCE OF THE ANCHOR FAST GUARD DEVICE IN OUR POST MARKETED DEVICE SURVEILLANCE SYSTEM FOR ANY ADVERSE TRENDS.

    Description of Event or Problem · 1

    HOLLISTER INCORPORATED BECAME AWARE ON 5/10/2019 OF A RESEARCH PAPER INVOLVING THE USE OF HOLLISTER ANCHOR FAST GUARD IN A RANDOMIZED TRIAL COMPARING THE GUARD TO TAPE TO SECURE ETT. THE ARTICLE IS CALLED, "THE EFFECT OF ADHESIVE TAPE VERSUS ENDOTRACHEAL TUBE FASTENER IN CRITICALLY ILL ADULTS: THE ENDOTRACHEAL TUBE SECUREMENT (ETTS) RANDOMIZED CONTROL TRIAL." THE ARTICLE WAS WRITTEN BY LANDSPERGER ET AL. AND PUBLISHED IN "CRITICAL CARE" (2019) 23:161, HTTPS://DOI.ORG/10.1186?S13054-019-2440-7. THE RESEARCH PAPER REPORTED OUTCOMES INCLUDING 6 PATIENTS WITH TUBE DISLODGEMENTS - WHICH WAS DEFINED AS OR NEEDING TO REPOSITION THE ENDOTRACHEAL TUBE MORE THAN 1 CM. THIS MDR IS FOR THE 5TH OF 6 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459182 ANCHORFAST GUARD ORAL ENDOTRACH TUBE FASTENER ANCHORFAST GUARD ORAL ENDOTRACH TUBE FASTENER CBH HOLLISTER INCORPORATED UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention