MAUDE Adverse Event Report: TELEFLEX MEDICAL TELEFLEX; LMA SUPREME

Model Number 175040

Device Problems Air Leak (1008); Dent in Material (2526)

Patient Problem No Information (3190)

Event Date 03/15/2017

Event Type  Injury  

Event Description

Large air leak noted approx 90 minutes of insertion of device.Manipulation of the device in situ in order to alleviate air leak was initiated.Upon completion of surgical procedure and removal of the supraglottic airway, a large dent was noted where the cuff of the supraglottic airway connected to the curved shaft of the device.

• Brand Name: TELEFLEX
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC 27709
• MDR Report Key: 6854412
• MDR Text Key: 85751849
• Report Number: MW5072065
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2018
• Device Model Number: 175040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 89