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

Model Number E4-421214

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2023

Event Type  malfunction  

Event Description

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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): APPLIED MEDICAL TECHNOLOGY, INC.; 8006 katherine blvd; brecksville OH 44141
• MDR Report Key: 19031408
• MDR Text Key: 339230933
• Report Number: 19031408
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: 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: 04/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: E4-421214
• Device Catalogue Number: E4-421214, 4-421214
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 88 KG
• Patient Race: White