MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SIZE 4

Model Number IPN922900

Device Problem Leak/Splash (1354)

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

Event Date 03/06/2023

Event Type  malfunction  

Event Description

Reported issue: the mask did not work well since it does not fit well.It presented an escape.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Corrected data: section b.5.- event description corrected.

Event Description

The issue was reported as: "the mask did not work well since it does not fit well.I present an escape.".The issue was detected during use.There was no patient injury or consequence.The condition of the patient was reported as "fine".Additional information has been requested in regards to the complaint description; however, nothing has been received at the time of this report.

• Brand Name: LMA UNIQUE SIZE 4
• Type of Device: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16703959
• MDR Text Key: 312909225
• Report Number: 9681900-2023-00011
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318259
• UDI-Public: 15060112318259
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN922900
• Device Catalogue Number: 125040
• Device Lot Number: 11F22B0078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED