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

Model Number	4-421214
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	10/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was originally reported to amt on 10/24/2023 by (b)(6) of(b)(6) hospital.At this time, it was reported that the bridle devices were getting pulled to the side and causing damage to the outside of the nares area.No device was available for inspection, but images were provided.From these it was concluded that the bridle pro was being placed too tightly, against the device's instructions for use.This caused minor skin level damage and redness.The hospital also noted they were planning further education training with these devices.On 04/03/2024, amt was notified of a medwatch report regarding this occurrence.There was no information provided that a death, serious injury, or any other harm occurred with the patient.A response is being sent to fda as the incident was reported under medwatch report #(b)(4).Based on the provided information and examination of the reported images, there was no evidence found that would indicate the device failed or that reported event was due to a manufacturing defect or quality issue.We have assigned the internal complaint # (b)(4) to this record.
Event or Problem Description
Per the original reporter in uf #(b)(4): the "envue and bridle have been in for weeks.Bridle noted to be embedded in pt outer septum on inside of right nare.The envue was sitting on pt left side with tube feeding infusing.The bridle had scabbed into the deep portion of the pressure injury.Bridle removed by physician.".

• Brand Name: AMT BRIDLE PRO
• Common Device Name: 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 44141
• Manufacturer Contact: ellyn smith ; 8006 katherine boulevard; brecksville, OH 44141 ; 4402622539
• MDR Report Key: 19238476
• Report Number: 1526012-2024-00007
• Device Sequence Number: 8049110
• Product Code: KNT
• UDI-Device Identifier: 00842071115883
• UDI-Public: 00842071115883
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K142971
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4-421214
• Device Catalogue Number: 4-421214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Unknown
• Patient Weight: 88 KG
• Patient Race: White