MAUDE Adverse Event Report: APPLIED MEDICAL TECHNOLOGY, INC. AMT BRIDLE; NASAL TUBE RETAINING SYSTEM

Model Number 4-4108

Device Problem Off-Label Use (1494)

Patient Problems Bone Fracture(s) (1870); Skin Tears (2516)

Event Type  malfunction  

Manufacturer Narrative

Per the original reporter, the doctor detailed that they did not blame the bridle for the harm to the patient, but that it was caused by being left in well beyond the indicated timeframe in the instructions for use.The device is indicated to be used in patients for up to 30 days, and the doctor reported that the device was left in use for about a year before erosion began.The device was not kept by the reporter so no examination of the device can be performed.The lot information was also not available.The complaint is being reported to fda due to the injury that was reported from the use of the device, though the injury was caused by misuse well beyond the indications of the device, which the reporting doctor confirms.There was no indication that a malfunction occurred with the device.Amt has logged this complaint in our system for trending purposes in complaint #: (b)(4).

Event Description

Doctor reported that the bridle was in place fin a small child for over a year, much longer than the 30 day indication, after which it gradually started to erode through the vomer bone and septum.

• Brand Name: AMT BRIDLE
• Type of Device: NASAL TUBE RETAINING SYSTEM
• 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
• MDR Report Key: 17981502
• MDR Text Key: 326475763
• Report Number: 1526012-2023-00011
• Device Sequence Number: 1
• Product Code: KNT
• 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
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 4-4108
• Device Catalogue Number: 4-4108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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