MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE SILICONE PILOT BALLOON SIZE 4; AIRWAY, OROPHARYNGEAL, ANESTH

Catalog Number	105300-000040
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Erythema (1840); Pain (1994)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: " i have taken care of a 15 year old boy twice, both times using an lma for under an hour.On both occasions the patient complained of significant throat pain for several days post operatively.Based on his first experience, the second time i cared for him i sized down to a '3, underinflated the cuff, lubricated generously and neither time was there any difficulty in placing the lma or blood on it when removed to indicate any trauma.He has lost 6 lbs since surgery as he is unable to swallow." photo shows erythema at the back of the throat.Additional information: "the patient is a 15 yr old male, 5' 7" 150 lbs no significant medical history.I referred the patient to an ent for evaluation on post op day 6.The ent placed the patient on a course of steroids and pain medication.It is now one week after treatments initiated by the ent and patient's throat pain has resolved.".
Additional Manufacturer Narrative
(b)(4).
Additional 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.
Event or Problem Description
It was reported that: " i have taken care of a 15 year old boy twice, both times using an lma for under an hour.On both occasions the patient complained of significant throat pain for several days post operatively.Based on his first experience, the second time i cared for him i sized down to a '3, underinflated the cuff, lubricated generously and neither time was there any difficulty in placing the lma or blood on it when removed to indicate any trauma.He has lost 6 lbs since surgery as he is unable to swallow." photo shows erythema at the back of the throat.Additional information: "the patient is a 15 yr old male, 5' 7" 150 lbs no significant medical history.I referred the patient to an ent for evaluation on post op day 6.The ent placed the patient on a course of steroids and pain medication.It is now one week after treatments initiated by the ent and patient's throat pain has resolved.".

• Brand Name: LMA UNIQUE SILICONE PILOT BALLOON SIZE 4
• Common Device Name: AIRWAY, OROPHARYNGEAL, ANESTH
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY (M) SDN. BHD; lot 19 , jalan hi-tech 3; zon industri fasa 1, kulim hi-tech park; kulim kedah 09090 ; MY 09090
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20924811
• Report Number: 3009307931-2024-00035
• Device Sequence Number: 17404091
• Product Code: CAE
• UDI-Device Identifier: 15060112319362
• UDI-Public: (01)15060112319362(11)240203(17)270202(10)11F24A0286(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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 Catalogue Number: 105300-000040
• Device Lot Number: 11F24A0286
• 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: 11/20/2024
• Supplement Date Received by Manufacturer: 01/09/2025
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Male