Complications Associated With AMT Nasal Bridle Use: An FDA MAUDE Analysis

ABSTRACT Nasal bridles have been used with increasing frequency and can be deployed at bedside. They are effective in reducing dislodgement of nasogastric tubes in the hospital setting and may increase caloric intake. Adverse events associated with device malfunction or improper use can occur and have a detrimental effect on patients. This study utilized the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to explore patient‐related adverse events associated with nasal bridle use between 2000 and 2023. Twenty‐four unique adverse events were reported: 15 were associated with foreign body retention, 4 with septal laceration on placement or removal, 3 from septal tears secondary to forceful patient removal, 1 associated with skin irritation, and 1 pressure necrosis. Fourteen of the 24 events were classified as device malfunction, 9 as patient‐related injury, and 1 as other. Despite their usefulness, they are not without risks, and clinicians should be aware of the potential issues.

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Publication Details

Journal
World Journal of Otorhinolaryngology - Head and Neck Surgery
Published
2025-06-24
DOI
https://doi.org/10.1002/wjo2.70036
Primary Topic
Nasal Surgery and Airway Studies
Type
article
Field-Weighted Citation Impact
0.00
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article

Complications Associated With AMT Nasal Bridle Use: An FDA MAUDE Analysis

Douglas R. Sidell, Noel Ayoub, David R. Grimm
World Journal of Otorhinolaryngology - Head and Neck Surgery
Nasal Surgery and Airway Studies
article

Complications Associated With AMT Nasal Bridle Use: An FDA MAUDE Analysis

Douglas R. Sidell, Noel Ayoub, David R. Grimm
article en

Abstract

ABSTRACT Nasal bridles have been used with increasing frequency and can be deployed at bedside. They are effective in reducing dislodgement of nasogastric tubes in the hospital setting and may increase caloric intake. Adverse events associated with device malfunction or improper use can occur and have a detrimental effect on patients. This study utilized the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database to explore patient‐related adverse events associated with nasal bridle use between 2000 and 2023. Twenty‐four unique adverse events were reported: 15 were associated with foreign body retention, 4 with septal laceration on placement or removal, 3 from septal tears secondary to forceful patient removal, 1 associated with skin irritation, and 1 pressure necrosis. Fourteen of the 24 events were classified as device malfunction, 9 as patient‐related injury, and 1 as other. Despite their usefulness, they are not without risks, and clinicians should be aware of the potential issues.

World Journal of Otorhinolaryngology - Head and Neck Surgery
Palo Alto University (US), Stanford Medicine (US), Stanford University (US)
Openalex Percentile: Top 75%
Nasal Surgery and Airway Studies
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Complications Associated With AMT Nasal Bridle Use: An FDA MAUDE Analysis — Douglas R. Sidell, Noel Ayoub, et al. · World Journal of Otorhinolaryngology - Head and Neck Surgery (2025) | TGRS Research Map | TGRS