MAUDE Adverse Event Report: THE LARYNGEAL MASK COMPANY LMA PROSEAL, REU, SIZE 3; LARYNGEAL MASK AIRWAY

Catalog Number 15130

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 02/17/2016

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 customer alleges the cuff (boot) was observed to be torn prior to insertion.There was no patient involvement reported.

Manufacturer Narrative

(b)(4).A 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 standard operating methods.The sample was received and observed to be used with blue marks on the cuff surface.The introducer strap was observed damaged/torn upon receipt.After closer observation a cut was found in the area of the reported failure.After ten (10) cycles of connecting and disconnecting the introducer from the proseal, there was no tear or damage observed.The reported complaint was confirmed by visual and functional inspection.Customer is reminded the device is made of soft silicone material and should be handled with care.Attaching the introducer strap into the proseal does not require heavy force.When washing/handling the device the customer should not pull the introducer strap with abrupt force otherwise this will cause irreparable damage.It is suspected the introducer strap was damaged due to handling after 8 cycles of use.

Event Description

The event is reported as: the customer alleges the cuff (boot) was observed to be torn prior to insertion.There was no patient involvement reported.

• Brand Name: LMA PROSEAL, REU, SIZE 3
• 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: 5482683
• MDR Text Key: 39756773
• Report Number: 9681900-2016-00011
• 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: 02/24/2016

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: 15130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2016
• 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