MAUDE Adverse Event Report: KINDWELL MEDICAL EQUIPMENT E-Z AIRWAY LARYNGEAL MASK; LMA

Model Number 1-2300-40

Device Problems Difficult to Insert (1316); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Sore Throat (2396)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

The tongue is getting caught in the opening of the lma and making insertion difficult.The user began using a different technique to avoid tongue by reverse insertion and 180 degree rotation.However, this caused mild bleeding and sore throat for pts.Went back to original technique.See scanned page.

• Brand Name: E-Z AIRWAY LARYNGEAL MASK
• Type of Device: LMA
• Manufacturer (Section D): KINDWELL MEDICAL EQUIPMENT; nankai district, tianjin ; CH
• Manufacturer (Section G): SUNMED; 12393 belcher rd. #450; largo FL 33773
• Manufacturer Contact: 12393 belcher rd. #450; largo, FL 33773
• MDR Report Key: 4146720
• MDR Text Key: 20015295
• Report Number: 1036445-2014-00006
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1-2300-40
• 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: 07/18/2014
• Distributor Facility Aware Date: 06/18/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1