MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA PROTECTOR CUFF PILOT SIZE 3

Catalog Number 192030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Numbness (2415)

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Customer reports patients experiencing tongue numbness for a period of days, or several weeks following anesthesia using the lma protector.The cases are performed with the patient in a supine position with their head and neck in neutral, and the cuff pressure is measured using a manometer, and the pressure maintained between 40-60 cm of water.No report of a required intervention.Tongue numbness resolved.The patient's condition is reported as fine.

Manufacturer Narrative

(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 Description

Customer reports patients experiencing tongue numbness for a period of days or several weeks following anesthesia using the lma protector.The cases are performed with the patient in a supine position with their head and neck in neutral and the cuff pressure is measured using a manometer and the pressure maintained between 40-60 cm of water.No report of a required intervention.Tongue numbness resolved.The patient's condition is reported as fine.

• Brand Name: LMA PROTECTOR CUFF PILOT SIZE 3
• Type of Device: LMA PROTECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10778718
• MDR Text Key: 214564118
• Report Number: 9681900-2020-00019
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2020

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
• Device Operator: Health Professional
• Device Catalogue Number: 192030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/03/2020
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.