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Maxima 5702042Recalls & reported problems

Henry Schein, Inc. · Class 2

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 10304040138882), received between Nov 1, 2022 and Nov 1, 2022 — classified as 1 injury.

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

Patient problems

  • Blister1
  • Hypersensitivity/Allergic reaction1
  • Skin Inflammation/ Irritation1

Recent adverse event reports

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

  • InjuryNov 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AN EMPLOYEE BROKE OUT AND HAD TROUBLE BREATHING SEVERAL DIFFERENT TIMES FORM WEARING THIS MASK. AS A RESULT THE PERSON SOUGHT MEDICAL CARE FOR THIS REACTION. THE 68 YEAR OLD FEMALE CLERK HAD REDNESS, SEVERE SWELLING AND BLISTERING ON FACE, WORSE WHERE THE MASK WAS. HER VOICE WAS HOARSE AND FELT LIKE THEIR THROAT WAS CLOSING UP.

    Patient problems: Blister; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

    MAUDE report 15710500 ↗

Other Mask, surgical devices

All Mask, surgical devices →

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