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

Catalog Number 105220-000040

Device Problem Material Too Rigid or Stiff (1544)

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

Event Date 06/11/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges the device was too rigid.The customer also reported there was slightly more trauma to the pt than anticipated.There was no reported injury to the pt.

Manufacturer Narrative

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

• Brand Name: LMA SURE SEAL, SU, CP, SIL., REINFORCED, 4
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): TELEFLEX ASIA PTE LTD; 6 battery rd, #07-02; singapore 0499 09; SN 049909
• Manufacturer (Section G): TELEFLEX ASIA PTE LTD; 6 battery rd, #07-02; singapore 0499 09; SN 049909
• Manufacturer Contact: warrenda peterson ; po box 12600; durham, NC 27709 ; 9193613959
• MDR Report Key: 3994036
• MDR Text Key: 4820309
• Report Number: 9681900-2014-00044
• 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