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Dale Endotracheal Tube Holder 270Recalls & reported problems

Dale Medical Products, Inc. · Dale Endotracheal Tube Holder, Fits ET Tube sizes 7.0mm - 10.0mm · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
6
Deaths reported
0
Injuries reported
6
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00817612020506), received between Apr 5, 2022 and Apr 5, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Use of Device Problem” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem4
  • Use of Device Problem2

Patient problems

  • Pressure Sore/Ulcer2
  • Tissue Breakdown2
  • Inflammation1
  • Skin Discoloration1
  • Unspecified Tissue Injury1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem

    "PATIENT HAS A SMALL INDENTATION ON THE UPPER LIP FROM ET TUBE HOLDING DEVICE. SLIGHT DISCOLORATION IS SEEN ON THE OUTSIDE OF THE UPPER LIP."

    Patient problems: Skin Discoloration

    MAUDE report 14015362 ↗
  • InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem

    "PATIENT HAS PRESSURE WOUND TO THE INSIDE OF HIS UPPER LIP FROM ET TUBE. THERE ARE NUMEROUS SPOTS OF BREAKDOWN INSIDE THE FRONT UPPER LIP."

    Patient problems: Pressure Sore/Ulcer; Tissue Breakdown

    MAUDE report 14014670 ↗
  • InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem

    "PATIENT HAS A SMALL RED SORE ON THE FRONT SIDE OF HIS UPPER GUMS."

    Patient problems: Inflammation

    MAUDE report 14014455 ↗
  • InjuryApr 5, 2022Adverse Event Without Identified Device or Use Problem

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

    Patient problems: Unspecified Tissue Injury

    MAUDE report 14013953 ↗
  • InjuryApr 5, 2022Use of Device Problem

    "PATIENT DEVELOPED SEVERE FACIAL WOUND UNDER DALE ET HOLDER DEVICE."

    Patient problems: Tissue Breakdown

    MAUDE report 14013282 ↗
  • InjuryApr 5, 2022Use of Device Problem

    "PATIENT HAS SMALL PRESSURE WOUND ON THE INSIDE OF HER UPPER LEFT LIP AND GUM AREA."

    Patient problems: Pressure Sore/Ulcer

    MAUDE report 14013193 ↗

Other Device, Fixation, Tracheal Tube devices

All Device, Fixation, Tracheal Tube devices →

Sources and updates

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