Skip to content

Procedural Earloop Mask GCPBL100Recalls & reported problems

Crosstex International, Inc. · Blue, Bulk Pack-100/box · Class 2

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 10732224120383), received between Sep 15, 2021 and Sep 15, 2021 — classified as 1 malfunction.

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

  • Local Reaction1
  • Rash1

Recent adverse event reports

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

  • MalfunctionSep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE USER FACILITY REPORTED THAT WHEN WEARING THE CROSSTEX PROCEDURAL EARLOOP MASK, 3 STAFF MEMBERS NOTED RASHES ON THEIR FACE AND A "STRONG CHEMICAL SMELL." ALL SYMPTOMS WERE RESOLVED BY REMOVING THE MASK. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED AND NO FURTHER REPORTS OF HARM OR ADVERSE REACTION WERE REPORTED FROM THE FACILITY.

    Patient problems: Local Reaction; Rash

    MAUDE report 12475273 ↗

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.