MAUDE Adverse Event Report: AES, INC. AED, INC.; SINGLE USE LARYNGEAL MASK

Catalog Number 1036040

Device Problems Material Fragmentation (1261); Defective Device (2588); Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/29/2014

Event Type  Injury  

Event Description

Event occurred after surgical procedure was complete, but during pt emergence from anesthesia.While attempting to extubate the #4 lma (lot # 402016940), the lma cuff detached from the shaft and the balloon detached from the cuff.A small fragment of the cuff broke off also.

• Brand Name: AED, INC.
• Type of Device: SINGLE USE LARYNGEAL MASK
• Manufacturer (Section D): AES, INC.; 2430 roberts drive; black diamond WA 98010
• MDR Report Key: 3918344
• MDR Text Key: 16186864
• Report Number: 3918344
• Device Sequence Number: 1
• Product Code: CAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 1036040
• Device Lot Number: 402016940
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2014
• Distributor Facility Aware Date: 05/29/2014
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/30/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR