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

Model Number	IPN039839
Medical Device Problem Code	Structural Problem (2506)
Health Effect - Clinical Code	Ecchymosis (1818)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem 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 or Problem 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".
Additional 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
• Common Device Name: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11858173
• Report Number: 3011137372-2021-00138
• Device Sequence Number: 17148093
• Product Code: CAE
• UDI-Device Identifier: 15060112315784
• UDI-Public: 15060112315784
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: IPN039839
• Device Catalogue Number: 105300-000050
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1