AVANOS 46927Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770469270), received between Aug 2, 2021 and Aug 14, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2021Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT THE PATIENT'S REPLACEMENT TUBE WAS CHECKED ON (B)(6) 2021 BY GASTROENTEROLOGIST IN DIGESTIVE ENDOSCOPY. ON (B)(6) 2021, THE PATIENT HAD BLOOD REFLUX IN THE TUBE AND VISUALIZATION OF TUBE MIGRATION UNDER SCANNER.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 12322146 ↗
• InjuryAug 2, 2021Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 3006646024-2021-00014 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE TUBE WAS PLACED ON (B)(6) 2021. "LEAK AROUND THE TUBE AND THEN BIOLOGICAL SEPSIS WITH A CRP [C-REACTIVE PROTEIN] AT 104." MIGRATION OF THE TUBE WAS NOTED IN THE ABDOMINAL WALL. THERE WAS A SURGICAL INTERVENTION ON (B)(6) 2021 TO TREAT THE ABSCESS. THE TUBE WAS FIXED TO THE SKIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Abscess; Device Embedded In Tissue or Plaque; Sepsis

  MAUDE report 12260109 ↗
• MalfunctionAug 2, 2021Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3006646024-2021-00015 FOR THE SECOND REPORT . IT WAS REPORTED THAT THE TUBE WAS PLACED ON (B)(6) 2021. ON (B)(6) 2021, MIGRATION OF THE TUBE WITH THE RETENTION RING "INCARCERATED" IN THE ABDOMINAL WALL WAS NOTED. THE TUBE WAS REMOVED AND CHANGED WITHOUT PROBLEM. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12260098 ↗