n/a SO-1945-0Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00607411100246), received between Aug 9, 2019 and Aug 9, 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

Recent adverse event reports

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

• InjuryAug 9, 2019Patient-Device Incompatibility

  I HAVE BEEN ON OXYGEN OVER TWENTY YEARS (OVER TIME, THE SUPPLIER COMPANY CHANGED). ABOUT FIVE YEARS AGO I NOTICED A BURNING PAIN BEHIND MY RIGHT EAR. IT CAME AND WENT BUT WAS WORSE AND LARGER EACH TIME. I STARTED SEEING A DERMATOLOGY DR REPEATED BIOPSY WERE DONE, THEN I HAD TO HAVE THE MDU MICROGRAPHIC SURGERY, WHERE AS THE ENTIRE BACK OF MY EAR WAS REMOVED TO THE HAIR LINE TOP TO CHIN BONE. I QUESTIONED THE DR AS TO THE "CANNULA" HOSE CAUSING THE PROBLEM, HE MADE NO COMMENT YES OR NO. HOWEVER, I KNOW THAT THIS IS THE CAUSE BECAUSE THE EAR THAT THE SURGERY WAS DONE ON, NOW HAS A NEW ONE, WHERE THE HOSE NOW LAYS. JUST OFF THE SCAR AND MY LEFT EAR SAME LOCATION, SAME PROBLEM (NO SURGERY YET) AS WELL AS THE NOSTRILS OF MY NOSE COLOR CHANGE, WEEPING, BURNING, GOES AWAY, COMES BACK BIGGER. ON (B)(6) 2019, AGAIN SAW DR (B)(6), WHO AGAIN STARTED. DRY SKIN YET IT IS THE EXACT ONE AS BEFORE FORMING WHERE THE CANNULA HOSE TOUCHES THE CHIN. MY LEFT EAR IS REAL SORE, BURNING, WEEPING, AND GETTING BIGGER. BUT, I AM BEING TOLD THAT NO ONE HAS EVER HAD SKIN CANCER, FROM AN OXYGEN HOSE? THE OXYGEN COMPANY IS (B)(6). I NEVER HAD THIS UNIT UNTIL I WAS ASSIGNED THIS COMPANY. SUICIDAL, CHRONIC PAIN.

  Patient problems: Burning Sensation; Pain; Skin Irritation

  MAUDE report 8880414 ↗