MAUDE Adverse Event Report: BELL MEDICAL PATIL-SYRACUSE; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Device Problems Loose or Intermittent Connection (1371); Migration or Expulsion of Device (1395); Material Split, Cut or Torn (4008)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/14/2008

Event Type  Injury  

Event Description

An incident apparently occurred on (b)(6) 2008, involving what has been only loosely described as a "patil-syracuse" type face mask.During this incident, physicians apparently performed an "intubation" through a "diaphragm covered port" in a patil? syracuse type mask.The physicians allegedly tore part of the port diaphragm loose (likely when the endo tracheal tube was pushed through it), and unknowingly lodged a diaphragm fragment in the patient's lungs.Our company (anesthesia associates, inc.[williams]) began manufacturing a patil?syracuse type face mask on 12/08/2008, which is after the (b)(6) 2008 incident date.Therefore, anesthesia associates, !nc.[williams] could not have been the manufacturer.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PATIL-SYRACUSE
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): BELL MEDICAL
• MDR Report Key: 17516387
• MDR Text Key: 321052943
• Report Number: MW5123336
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2012

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2023
• Patient Sequence Number: 1