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NA 7210563Recalls & reported problems

Smith & Nephew, Inc. · T-MAX INTUBATION DRAPER BAR · 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 03596010513762), received between May 10, 2021 and May 10, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unstable” (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

  • Unstable1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionMay 10, 2021Unstable; Unstable

    IT WAS REPORTED THAT DURING ARTHROSCOPY PROCEDURE, OUTSIDE THE PATIENT, THE INTUBATION DRAPER BAR COULD NOT BE ATTACHED TO A HEAD REST, CAME OFF DURING THE SURGERY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE TO STRENGTHEN THE FIXATION BY SURGICAL DRAPE. NO SURGICAL DELAY. NO PATIENT INJURIES AND COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11798648 ↗

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