Vanish™ 12150LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30605861013131), received between Apr 13, 2018 and Apr 13, 2018 — 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryApr 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, A DENTIST REPORTED THAT A (B)(6) FEMALE PATIENT EXPERIENCED SHORTNESS OF BREATH WITHIN 5 MINUTES AFTER APPLICATION OF 3M ESPE VANISH¿ 5% SODIUM FLUORIDE WHITE VARNISH (MELON FLAVOR); THE DENTIST HAD THE PATIENT RINSE AND BRUSH OFF THE VARNISH PRIOR TO LEAVING THE OFFICE. THE PATIENT WENT TO THE EMERGENCY ROOM LATER THAT SAME DAY, WHERE BENADRYL WAS ADMINISTERED INTRAVENOUSLY AND ONE EPINEPHRINE INJECTION WAS ADMINISTERED. OTHER PRODUCTS USED DURING THE DENTAL APPOINTMENT INCLUDED A NON-3M BRAND OF PROPHY PASTE. CURRENT PATIENT STATUS IS FINE.

  Patient problems: Dyspnea

  MAUDE report 7430871 ↗