MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 2

Model Number	IPN922808
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/08/2021
Type of Reportable Event	Serious Injury
Event or Problem 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".
Additional Manufacturer Narrative
(b)(4).
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.
Event or Problem 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
• Common Device Name: 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
• Report Number: 9681900-2022-00002
• Device Sequence Number: 17512726
• Product Code: CAE
• UDI-Device Identifier: 15060112318068
• UDI-Public: 15060112318068
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 01/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Life Threatening
• Patient Sex: Unknown