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CONVERTORS AT74635-IRecalls & reported problems

Cardinal Health 200, LLC · Surgical Mask W/Anti-Fog Foam Strip and Wraparound Eye Shield · 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 20885380072151), received between Apr 8, 2019 and Apr 8, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

  • Patient-Device Incompatibility1

Patient problems

  • Hypersensitivity/Allergic reaction1

Recent adverse event reports

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

  • InjuryApr 8, 2019Patient-Device Incompatibility

    NURSE STATES ¿DURING THE PROCEDURE MY NOSE WAS ITCHING, BY THE END OF THE DAY I HAD HIVES AROUND THE RIGHT SIDE OF MY MOUTH. THE NEXT DAY MY WHOLE FACE WAS SWOLLEN¿. SHE SAW A PHYSICIAN AND WAS TOLD TO KEEP TAKING BENADRYL EVERY 6 HOURS AND WAS PRESCRIBED A PREDNISONE PACK FOR 6 DAYS.

    Patient problems: Hypersensitivity/Allergic reaction

    MAUDE report 8492342 ↗

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.