MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 2

Model Number IPN922808

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematoma (1884)

Event Date 12/08/2021

Event Type  Injury  

Event Description

It was reported that: "the child had general anesthesia with a size 2 laryngeal mask for adenoidectomy.Adenoidectomy [was] complicated by a hematoma of the uvula responsible for anorexia for 48 hours.Ent consultation 48 hours post-operative.Anesthetist found the laryngeal mask end too hard and too sharp".

Manufacturer Narrative

(b)(4).

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.

Event Description

It was reported that: "the child had general anesthesia with a size 2 laryngeal mask for adenoidectomy.Adenoidectomy [was] complicated by a hematoma of the uvula responsible for anorexia for 48 hours.Ent consultation 48 hours post-operative.Anesthetist found the laryngeal mask end too hard and too sharp".

• Brand Name: LMA SUPREME SIZE 2
• Type of Device: LMA SUPREME
• 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
• MDR Report Key: 13151639
• MDR Text Key: 283145794
• Report Number: 9681900-2022-00002
• Device Sequence Number: 1
• Product Code: CAE
• UDI-Device Identifier: 15060112318068
• UDI-Public: 15060112318068
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN922808
• Device Catalogue Number: 175020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/13/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening