MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 5

Model Number IPN902076

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "when the doctor used it he found the inflation line was kinked and therefore the valve wouldn't inflate.He removed the mask and changed to an igel".No patient injury or consequence reported.Patient condition reported as "fine".

Event Description

It was reported that "when the doctor used it he found the inflation line was kinked and therefore the valve wouldn't inflate.He removed the mask and changed to an igel".No patient injury or consequence reported.Patient condition reported as "fine".

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.

• Brand Name: LMA SUPREME SIZE 5
• Type of Device: LMA SUPREME
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 12086484
• MDR Text Key: 258989136
• Report Number: 9681900-2021-00020
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 05060112310836
• UDI-Public: 05060112310836
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/07/2021

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 Expiration Date: 02/28/2023
• Device Model Number: IPN902076
• Device Catalogue Number: 175050
• Device Lot Number: QMAM43
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/07/2021
• Initial Date FDA Received: 06/29/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IGEL LMA; IGEL LMA; IGEL LMA