MAUDE Adverse Event Report: KINDWELL MED EQUIPMENT CO., LTD ULTRA CLEAR LARYNGEAL MASK AIRWAY

Catalog Number 1036040

Device Problem Misassembled (1398)

Patient Problem No Information (3190)

Event Date 05/29/2014

Event Type  Injury  

Event Description

Laryngeal mask airway cuff separated from tube while pt was being extubated.

• Brand Name: ULTRA CLEAR LARYNGEAL MASK AIRWAY
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): KINDWELL MED EQUIPMENT CO., LTD; nankai district, tianjin ; CH
• MDR Report Key: 3878147
• MDR Text Key: 4512643
• Report Number: 3022477-2014-00002
• 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: Distributor
• Source Type: Unknown
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/05/2014

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 Expiration Date: 02/01/2019
• Device Catalogue Number: 1036040
• Device Lot Number: 402016940
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/05/2014
• Distributor Facility Aware Date: 05/29/2014
• Device Age: 3 MO
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 06/05/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR