MAUDE Adverse Event Report: MCKESSON MCKESSON; LARYNGEAL MASK AIRWAY ADULT

Model Number	159-005
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	04/23/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report has not been returned.A review of the device history record is in-progress.All information reasonably known as of 21 may 2026 has been included in the health authority report.Should additional information be obtained a follow-up health authority report will be provided.The information provided by airlife.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to airlife.Airlife has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the airlife complaint database and is identified as complaint- (b)(4).This information is submitted pursuant to 21 cfr 803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a airlife product is defective or causes serious injury.
Event or Problem Description
It was reported that a patient required stitches to the back of the throat following the use of an laryngeal mask airway size 5 from mckesson.The crna noted that the plastic appeared to be harder compared to a previously used product (teleflex).The patient was advised to follow up with the surgeon if any issues arise.No additional information regarding the patient's outcome was provided.

• Brand Name: MCKESSON
• Common Device Name: LARYNGEAL MASK AIRWAY ADULT
• Manufacturer (Section D): MCKESSON; 9954 mayland drive; ste 4000; richmond VA 23233
• Manufacturer (Section G): SUNMED AP, LTD.; 6-9 zhufeng rd., qiannan indus; qianwu town, doumen district; zhuhai guangdong, 51917 0; CH 519170
• Manufacturer Contact: candacy bush ; 2710 northridge dr. nw, suite a; grand rapids, MI 49544
• MDR Report Key: 25244654
• Report Number: 1314417-2026-00032
• Device Sequence Number: 10500907
• Product Code: CAE
• UDI-Device Identifier: 10612479224183
• UDI-Public: (01)10612479224183(10)2506010878
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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
• Operator of Device: Health Professional
• Device Model Number: 159-005
• Device Lot Number: 2506010878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male