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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Skin Erosion (2075)

Event Date 09/12/2022

Event Type  Injury  

Manufacturer Narrative

This report is a response to user facility report #(b)(4).Based on the provided information, the reported incident was not caused by a manufacturing defect.The device functioned as intended and there was no malfunction as defined by the fda, but it is believed the device was not properly placed according to instructions.Limited information was provided to amt regarding the injury that was caused to the patient.It was reported that the septum of the patient was damaged and intervention was required.Amt has reached out to the reporter to obtain clarifying information regarding the event, but no response has been received at this time.Based on the limited information available, it is believed that the device was improperly placed and was not placed around the vomer bone as required in the product instructions.We will continue to work with the original reporter to obtain additional information.We have assigned complaint # (b)(4) to this report and 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.

Event Description

Per the original fda report #: (b)(4), it was reported that: "while removing the bridle and nasogastric tube (ngt) from the patient, the bedside registered nurse (rn) and charge rn noticed that the patient was experiencing a lot of pain.When assessing, the septum of the patient had been cut and the bridle was stuck in-between the septum.The bridle was cut and slowly guided out of the septum/nose.Wound care was provided after removal.Md was notified and a wound care consult was placed.Package had been thrown out at the time the ng and bridle was placed.".

• 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: 15823531
• MDR Text Key: 303902902
• Report Number: 1526012-2022-00017
• 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: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• 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
• Patient Sex: Female