MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA UNIQUE (SILICONE CUFF) CPV SIZE 5

Catalog Number 105200-000050

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

Patient Problems Laceration(s) (1946); No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint reported as: "the patient went down for an mri with anesthesia which required intubation.When the patient arrived back to the floor he had what appeared to be a blood blister on the right upper part of his mouth by his tonsil, and there was a laceration and bleeding near his uvula.Both were bleeding a fair amount of bright red blood, requiring a one time suctioning of the patient and mouth swab cleaning.Prior to the test the patient was on a regular diet with no liquid restrictions, following the test the patient was having swallow issues and had to be placed on a honey thick liquid, puree diet." the patient's condition was reported as "fine".It was the customer's opinion the patient trauma was attributed to the device.Additional information was requested but not available at the time of this report.

Event Description

Complaint reported as: "the patient went down for an mri with anesthesia which required intubation.When the patient arrived back to the floor he had what appeared to be a blood blister on the right upper part of his mouth by his tonsil, and there was a laceration and bleeding near his uvula.Both were bleeding a fair amount of bright red blood, requiring a one time suctioning of the patient and mouth swab cleaning.Prior to the test the patient was on a regular diet with no liquid restrictions, following the test the patient was having swallow issues and had to be placed on a honey thick liquid, puree diet." the patient's condition was reported as "fine".It was the customer's opinion the patient trauma was attributed to the device.Additional information was requested but not available at the time of this report.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: LMA UNIQUE (SILICONE CUFF) CPV SIZE 5
• Type of Device: LMA UNIQUE
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9240784
• MDR Text Key: 190843190
• Report Number: 3011137372-2019-00370
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/08/2019

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: No Information
• Device Catalogue Number: 105200-000050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANESTHESIA; ANESTHESIA