MAUDE Adverse Event Report: COOKGAS LLC AIR-QSP; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Model Number 4035

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

Patient Problems Dysphagia/ Odynophagia (1815); Patient Problem/Medical Problem (2688)

Event Date 04/13/2017

Event Type  malfunction  

Event Description

Two women presented elective bunion surgery undergoing general anesthesia with air-q lma.After surgery and pt woke up she communicated that she was hoarse unable to cough or belch.Pt complained the day after surgery with difficulty swallowing and coughing with clear liquids.Pt was then seen by ent and her left vocal cord was not functioning properly.Pt was referred to a laryngologist.

• Brand Name: AIR-QSP
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): COOKGAS LLC; 1101 lucas ave.; ste. 200; saint louis MO 63101
• MDR Report Key: 6629946
• MDR Text Key: 77219275
• Report Number: 6629946
• 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: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/17/2017

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: Physician
• Device Model Number: 4035
• Device Lot Number: 140495D
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES; PT UNDERWENT BUNION SURGERY. UNEVENTFUL PLACEMENT
• Patient Age: 50 YR