AVANOS 44500Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770445007), received between Oct 23, 2020 and Oct 23, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Biocompatibility” (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.

• InjuryOct 23, 2020Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE FEEDING TUBE WAS PLACED ON (B)(6) 2020. THE PATIENT DEVELOPED A RASH AROUND THE STOMA SITE. IT WAS NOT CLEAR IF ITCHING, AND RASH WERE RELATED TO THE TUBE INSERTION OR REACTION TO A FEED. ADDITIONAL INFORMATION RECEIVED 02-OCT-2020 INDICATED THAT DURING THE FIRST WATER CHANGE FOR THE BALLOON, THE STOMA SITE LOOKED CLEAN WITH BUTTONS INSITU. RASH AND ITCHING SUBSIDED. THERE WAS SLIGHT SWELLING LEFT-SIDE OF STOMA, BUT, "LESSENING AND LESS PAINFUL." ADDITIONAL INFORMATION RECEIVED 07-OCT-2020 INDICATED THE FEEDING TUBE WAS PLACED BY A CONSULTANT RADIOLOGIST. THE NEXT DAY THE PATIENT STARTED ITCHING AND THIS GOT WORSE. PHYSICIAN PRESCRIBED ANTIHISTAMINES, WHICH THE PATIENT CONTINUES TO USE. MEDICATION AND FEEDING WERE STOPPED, AND ARE BEING INTRODUCED ONE AT A TIME OVER THE NEXT TWO WEEKS. CAUSE OF RASH STILL UNKNOWN; PATIENT HAS REACTED TO PLASTERS IN THE PAST.

  Patient problems: Itching Sensation; Rash; Swelling

  MAUDE report 10727133 ↗