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KIMBERLY-CLARK® FLUIDSHIELD™ PFR95™ Respirator and Surgical Mask 46767Recalls & reported problems

Kimberly-Clark Global Sales, LLC · N95 Particulate Filter Respirator and Surgical Mask · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 00036000467673), received between Jun 11, 2020 and Jun 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Disintegration” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Material Disintegration1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJun 11, 2020Material Disintegration

    I WAS GIVEN A DUCKBILL MASK THAT A STAFF MEMBER HAD TRIED TO USE THE PREVIOUS DAY. THE STRAPS TO THE MASK DISINTEGRATED IN HER HAND WHILE TRYING TO DON THE MASK. ON THE NEXT DAY, A DIFFERENT NURSE TRIED TO USE 2 DIFFERENT DUCKBILL MASKS AND BOTH MASKS STRAPS DISINTEGRATED IN HER HAND WHILE DONNING THE MASK. THESE MASKS WERE NEW. THERE HAVE NOT BEEN OTHER REPORTED EVENTS. STAFF DID NOT USE THESE MASKS. THEY WERE PROVIDED OTHER N-95'S TO WEAR AND NO HARM WAS NOTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10142541 ↗

Other Respirator,surgical devices

All Respirator,surgical devices →

Sources and updates

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