MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT 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

Per the original described event in mdr report #: mw5109861, "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).".

Manufacturer Narrative

This report is a response mdr report #: mw5109861.We have assigned complaint # (b)(4) to this report.Based on the reported information, there was no death nor did this result in permanent impairment or a serious injury that is life-threatening, as defined by the fda.Although there was no patient harm in this case and there is no chance of death or serious injury, additional intervention was required, thus this record is being reported.Amt has reached out to the initial reporter to see if the device is available for examination and we requested additional information regarding the report, but no response has been received at this time.We will provide additional information to the fda if the device or additional information is able to be obtained and its analysis changes the conclusion of this report.

• Brand Name: AMT BRIDLE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer (Section G): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine boulevard; brecksville OH 44141
• Manufacturer Contact: joshua meinke ; 8006 katherine boulevard; brecksville, OH 44141 ; 4407174000
• MDR Report Key: 14996099
• MDR Text Key: 304176746
• Report Number: 1526012-2022-00010
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00842071106645
• UDI-Public: 00842071106645
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142971
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4-4110
• Device Catalogue Number: 4-4110
• Device Lot Number: 211124-214
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other