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Essentials 1127299Recalls & reported problems

Henry Schein, Inc. · Essentials Mini C-Type PB HP · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00304040058213), received between Feb 15, 2018 and Feb 15, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fail-Safe Design Failure” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Fail-Safe Design Failure1
  • Use of Incorrect Control/Treatment Settings1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 15, 2018Use of Incorrect Control/Treatment Settings; Fail-Safe Design Failure; Use of Incorrect Control/Treatment Settings; Fail-Safe Design Failure

    BUR FLEW OUT OF HANDPIECE AND WENT DOWN TO PATIENT THROAT.

    Patient problems: Foreign Body In Patient

    MAUDE report 7275592 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.