MAUDE Adverse Event Report: TELEFLEX ASIA PTE LTD LAMA SURE SEAL, SU, CP, SIL., REINFORCED, 4; LARYNGEAL MASK AIRWAY

Catalog Number 105220-000040

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 06/01/2014

Event Type  malfunction  

Event Description

The device is reported as: the customer alleges the device did not create a good seal.There was no reported injury to the pt.

Manufacturer Narrative

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

• Brand Name: LAMA SURE SEAL, SU, CP, SIL., REINFORCED, 4
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): TELEFLEX ASIA PTE LTD; 6 battery road, #07-02; singapore 0499 09; SN 049909
• Manufacturer Contact: warrenda peterson ; po box 12600; durham, NC 27709 ; 9193613959
• MDR Report Key: 3994029
• MDR Text Key: 4888686
• Report Number: 9681900-2014-00045
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/08/2014

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 Catalogue Number: 105220-000040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2014
• Initial Date FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1