MAUDE Adverse Event Report: AMBU A/S AMBU AURASTRAIGHT; LAYRNGEAL MASK

Model Number 324150000

Device Problem Use of Device Problem (1670)

Patient Problems Dysphagia/ Odynophagia (1815); Sore Throat (2396); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

According to the instruction for use the user must perform a visual inspection of the product and also do an inflation/deflation test prior to use.These instructions and test cannot be followed properly without removing the cuff protector.The event is evaluated as an user error.User did not remove the cuff protector.As part of the complaint investigation the product risk evaluation has been reviewed.The reported problem is included in the risk analysis and the risk for a hazardous situation to occur as a result of the reported is concluded to be acceptable low.This incident happened in (b)(6).Device not returned.

Event Description

On (b)(6) 2016, a laryngeal mask was used on a (b)(6) girl undergoing an transtympanic aeration.During the intervention, the anesthesia nurse forgot to remove the cuff protector from the distal end of the laryngeal mask.The patient went out the hospital same day in good health.Later the patient developed dysphagia and aphagia and was diagnosed with pseudomembranous sore throat and treated with antibiotics with no improvement.Patient was hospitalized on (b)(6) 2016 and a feeding tube was placed.Patient underwent 3 mri scans ((b)(6) 2016), all non-conclusive.On (b)(6) a laryngo-tracheobronchial endoscopy was performed and a foreign body (the cuff protector) was removed from the pharynx of the patient.The patient improved rapidly allowing resumption of standard alimentation.

• Brand Name: AMBU AURASTRAIGHT
• Type of Device: LAYRNGEAL MASK
• Manufacturer (Section D): AMBU A/S; baltorpbakken 13; ballerup, denmark DK-27 50; DA DK-2750
• Manufacturer (Section G): AMBU INC; 6230 old dobbin lane; suite 250; columbia MD 21045
• Manufacturer Contact: sanjay parikh ; 6230 old dobbin lane; suite 250; columbia, MD 21045 ; 4107686464
• MDR Report Key: 5999840
• MDR Text Key: 56476030
• Report Number: 9610691-2016-00004
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: E221696
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 324150000
• Device Catalogue Number: 324150000
• Device Lot Number: 1585037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR
• Patient Weight: 14