MAUDE Adverse Event Report: LMA; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Device Problem Pressure Problem (3012)

Patient Problem Ulcer (2274)

Event Date 06/04/2021

Event Type  Injury  

Event Description

During surgery my anesthesiologist used an lma to administer anesthesia.The pressure from the device caused an ulcer on my throat.It's only been a few days and it's till there but isn't worsening at this point.Fda safety report id # (b)(4).

• Brand Name: LMA
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• MDR Report Key: 11976161
• MDR Text Key: 255774279
• Report Number: MW5101815
• Device Sequence Number: 1
• Product Code: CAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/07/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR