MAUDE Adverse Event Report: TELEFLEX ASIA PTE LTD. LMA SUPREME, SU, SIZE 4; LARYNGEAL MASK AIRWAY

Catalog Number 175040

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/27/2014

Event Type  malfunction  

Event Description

The event is reported as: the cuff of the device was identified as torn upon smooth removal of the airway after the surgery.

Manufacturer Narrative

The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.

• Brand Name: LMA SUPREME, SU, SIZE 4
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): TELEFLEX ASIA PTE LTD.; 6 battery road; #07-02; singapore 0499 09
• Manufacturer (Section G): TELEFLEX ASIA PTE LTD; 6 battery road; #07-02
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709
• MDR Report Key: 3824128
• MDR Text Key: 16803932
• Report Number: 9681900-2014-00007
• 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: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 175040
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1