Provox Luna Adhesive 8014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07331791009259), received between Dec 19, 2017 and Dec 19, 2017 — 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. 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.

• MalfunctionDec 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS THE INFORMATION THAT WAS RECEIVED FROM THE ATOS MEDICAL LOCAL REPRESENTATIVE: HUSBAND FOLLOWED INSTRUCTIONS AND PLACED LUNA ONTO HIS WIFE. PATIENT WOKE IN THE MIDDLE OF THE NIGHT AND THE BASE PLATE HAD COVERED HER STOMA. AFTER FURTHER DISCUSSIONS THE PATIENTS HUSBAND INFORMED ME THAT THEY BOTH HAD FLU AND WERE EXPERIENCING NIGHT SWEATS. ADDITIONAL INFO: · WAS THE SKIN CLEANED BEFORE THE ADHESIVE WAS APPLIED? YES, HUSBAND CLEANS THE SKIN EVERY TIME WITH ATOS WIPES, HE HAS BEEN DOING THIS FOR 14 YEARS AND DOES EVERYTHING BY THE BOOK. · IF THE SKIN WAS CLEANED WHAT CLEANING PRODUCTS WAS USED? ATOS WIPES. · WAS BODY LOTION OR OTHER MOISTURIZING CREAMS USED ON THE SKIN AROUND THE STOMA? NO - ABSOLUTELY DEFINITELY NO LOTIONS OR CREAMS USED . PT DIDN'T HAVE RADIOTHERAPY SO SKIN IS IN VERY GOOD CONDITION. · WAS THIS THE FIRST TIME THE CUSTOMER USED LUNA OR HAS SHE USED IT BEFORE? ANY PREVIOUS EXPERIENCE? THIS WAS THE FIRST TIME THE PATIENT HAD TRIED LUNA, SHE HAS HAD NO OTHER EXPERIENCES. NO PRODUCT WILL BE RETURNED FOR INVESTIGATION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7127936 ↗