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Complications Associated With AMT Nasal Bridle Use: An FDA MAUDE Analysis
David R Grimm1, Douglas R Sidell1, Noel F Ayoub1
1Department of Otolaryngology-Head & Neck Surgery, Division of Pediatric Otolaryngology Stanford University School of Medicine Palo Alto California USA.
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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