MAUDE Adverse Event Report: SUNMED HOLDINGS LLC SUNMED LLC; AIRQ3 STANDARD ILA WITH MANUAL CUFF INFLATION SIZE 5.0

Model Number 30505

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 02/09/2024

Event Type  Injury  

Manufacturer Narrative

The patient developed pressure ulcer on the tonsillar pillar.The improper placement or intubation process could have also been a cause for the patient's injury.

Event Description

Horrible pressure ulcer on a patient's tonsillar pillar. "an adult male patient that received a general anesthetic through air q lma size 5 2/9/2024 presented in follow up with horrible sore throat.On exam, there was an ischemic looking ulcer of the left tonsillar base that was tender and painful.".

Manufacturer Narrative

The patient developed pressure ulcer on the tonsillar pillar.The improper placement or intubation process could have also been a cause for the patient's injury.The complaint of "horrible pressure ulcer on a patient's tonsillar pillar" regarding part 30505 was not confirmed.The root cause cannot be determined but could possibly be a result of "device having sharp edges and corners at the patient end of the tracheal tube" which may have caused "scratching and trauma to tracheal and mucosal tissue".A risk assessment was performed, and the ultimate risk was determined to be low, which does not require the initiation of a capa.There has been 1 other complaint regarding an airq3 device and a similar issue within the 24 months preceding this reported issue.A resolution letter was sent to the customer.

Event Description

Horrible pressure ulcer on a patient's tonsillar pillar. "an adult male patient that received a general anesthetic through air q lma size 5 (b)(6) 2024 presented in follow up with horrible sore throat.On exam, there was an ischemic looking ulcer of the left tonsillar base that was tender and painful.".

• Brand Name: SUNMED LLC
• Type of Device: AIRQ3 STANDARD ILA WITH MANUAL CUFF INFLATION SIZE 5.0
• Manufacturer (Section D): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer (Section G): SUNMED HOLDINGS LLC; 2710 northridge dr nw suite a; grand rapids MI 49544
• Manufacturer Contact: melissa brickley ; 2710 northridge dr nw suite a; grand rapids, MI 49544 ; 6162598415
• MDR Report Key: 18918178
• MDR Text Key: 337844526
• Report Number: 1314417-2024-00016
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: 30505
• Device Catalogue Number: 30505
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/15/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Other