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

Catalog Number 175040

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); Numbness (2415)

Event Date 11/12/2013

Event Type  malfunction  

Event Description

The event is reported via maude report as: the pt has an apparent nerve injury following general anesthesia following airway management using a lma supreme size 4 for a two hour procedure.At that time numbness was reported.

Manufacturer Narrative

From the maude report there is no additional information as it relates to the pt condition or the name of the user/reporting facility.

• Brand Name: LMA SUPREME, SU, SIZE 4
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): TELEFLEX MED ASIA PTE LTD; 6 battery rd; #07-02; singapore 0499 09; SN 049909
• Manufacturer (Section G): TELEFLEX MEDICAL ASIA TE LTD; 6 battery rd; #07-02; singapore 0499 09; SN 049909
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3752978
• MDR Text Key: 4465854
• Report Number: 9681900-2014-00004
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Type of Report: Initial
• Report Date: 01/15/2014

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: Other
• Device Catalogue Number: 175040
• Device Lot Number: HMAA9J
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/15/2014
• Initial Date FDA Received: 02/05/2014
• 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: Unknown
• Patient Sequence Number: 1