MAUDE Adverse Event Report: TELEFLEX ASIA PTE LTD LMA FLEXIBLE, REU, SIZE 2.5; LARYNGEAL MASK AIRWAY

Catalog Number 11125

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges there was herniation of the cuff during use on a pt.There was no pt injury reported.The pt condition is fine.

Manufacturer Narrative

The device sample was not returned for evaluation at the time of this report.

• Brand Name: LMA FLEXIBLE, REU, SIZE 2.5
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): TELEFLEX ASIA PTE LTD; 6 battery rd, #07-02; 0499 09; SN 049909
• Manufacturer (Section G): TELEFLEX ASIA PTE LTD.; 6 battery rd, #07-02; 0499 09; SN 049909
• Manufacturer Contact: warrenda peterson, reg affairs ; p.o. box 12600; durham, NC 27709 ; 9193613959
• MDR Report Key: 3851586
• MDR Text Key: 17157330
• Report Number: 9681900-2014-00011
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1