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NA 7210559Recalls & reported problems

Smith & Nephew, Inc. · T-MAX DISPOSABLE FACE MASK 8 PER BOX · Class 1

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010513724), received between Oct 26, 2020 and Oct 26, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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

  • Adverse Event Without Identified Device or Use Problem1
  • Insufficient Device Problem Information1

Patient problems

  • Abrasion1
  • Injury1

Recent adverse event reports

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

  • InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

    IT WAS REPORTED THAT AFTER SURGERY WHEN THE FACE MAS WAS USED, DERMAL DAMAGE WAS CONFIRMED ON THE CHEEK OF THE PATIENT. THE PATIENT HAD BEEN POSITIONED FOR LESS THAN 2 HOURS DURING SURGERY AND THE ADJUSTMENT OF PATIENT POSITION AND FACE MASK. NO FURTHER COMPLICATIONS REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: Abrasion; Injury

    MAUDE report 10737816 ↗

Other Accessories, operating-room, table (kit) devices

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