MAUDE Adverse Event Report: THE LARYNGEAL MASK COMPANY LMA PROSEAL, REU, SIZE 2; LARYNGEAL MASK AIRWAY

Catalog Number 15120

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/30/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The event is reported as: the cuff is difficult to inflate.There was no patient involvement reported.

Manufacturer Narrative

(b)(4).Device history record (dhr) review was performed and there were no issues found that could have contributed to the reported failure.All processes were executed according to the standard operating methods.A sample was received and was observed to have been used and had a discolored red plug as compared to a retained sample.The device was not in the original teleflex lma packaging.The complaint sample also had stains and tiny loose particulate on the surface.The sample was difficult to inflate during the functional inspection, therefore the reported complaint was confirmed.Customer is reminded the lma proseal is reusable and warranted against manufacturing defects for forty (40) uses or a period of one (1) year from the date of purchase (whichever is earlier), subject to certain conditions.The device has been out of warranty since february 2013.

Event Description

The event is reported as: the cuff is difficult to inflate.There was no patient involvement reported.

• Brand Name: LMA PROSEAL, REU, SIZE 2
• Type of Device: LARYNGEAL MASK AIRWAY
• Manufacturer (Section D): THE LARYNGEAL MASK COMPANY; singapore
• Manufacturer (Section G): THE LARYNGEAL MASK COMPANY; 6 battery road #07-02; singapore 04990 9; SN 049909
• Manufacturer Contact: warrenda peterson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193613959
• MDR Report Key: 5264646
• MDR Text Key: 32623516
• Report Number: 9681900-2015-00063
• Device Sequence Number: 1
• Product Code: CAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2015

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: 15120
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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