MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE PILOT BALLOON SIZE 5

Model Number IPN039839

Device Problem Structural Problem (2506)

Patient Problem Ecchymosis (1818)

Event Date 05/03/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported "the chief of anesthesia informed me that two ent doctors said that the tip of the cuff was causing trauma/bruising to the patient's epiglottis".No patient desaturation reported.No medical intervention required.Patient condition reported as "fine".

Event Description

It was reported "the chief of anesthesia informed me that two ent doctors said that the tip of the cuff was causing trauma/bruising to the patient's epiglottis".No patient desaturation reported.No medical intervention required.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: LMA UNIQUE SILICONE PILOT BALLOON SIZE 5
• Type of Device: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11858173
• MDR Text Key: 251827014
• Report Number: 3011137372-2021-00138
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112315784
• UDI-Public: 15060112315784
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

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 Model Number: IPN039839
• Device Catalogue Number: 105300-000050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1