MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. 10 FRENCH BRIDLE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 4-4110

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/27/2022

Event Type  malfunction  

Event Description

While attempting to place dobhoff bridle, the magnet on the left side detached and lodged in the patient's nasopharynx.Multiple providers attempted to remove it non-invasively but were unsuccessful.The patient will need to undergo anesthesia to remove, but has elected to leave it in place unless it causes problems.Bilateral nasal cavities anesthetized with a 50/50 solution of 4% lidocaine and 0.05% oxymetazoline on 1/2x3" neuro patties.Bilateral cavities examined with a 0 degree hopkins rod telescope.Mucous was removed from the nasal cavities and nasopharynx with a frazier tip suction.No foreign bodies were identified.Fda safety report id# (b)(4).

• Brand Name: 10 FRENCH BRIDLE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 14488476
• MDR Text Key: 292612324
• Report Number: MW5109861
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4-4110
• Device Lot Number: 211124-214
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 40 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White