MAUDE Adverse Event Report: TELEFLEX MEDICAL LMA SUPREME SIZE 4; AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY

Catalog Number 175040

Device Problem Material Perforation (2205)

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

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint has not been received by the manufacturer for evaluation at the time of this report.

Event Description

Customer complaint alleges "while using the mask, the anesthetist realized that the cuff was perforated." there was no report of patient impact or consequence.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed on the cuff and no abnormalities were found.Leak testing was also performed and no issues were detected.The cuff was able to inflate and deflate normally.A device history record review was performed and there were no issues found that could relate to the reported complaint.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

Customer complaint alleges "while using the mask, the anesthetist realized that the cuff was perforated." there was no report of patient impact or consequence.

• Brand Name: LMA SUPREME SIZE 4
• Type of Device: AIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 7796970
• MDR Text Key: 117586827
• Report Number: 9681900-2018-00032
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/03/2018

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: 175040
• Device Lot Number: SN:MMAP2B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/20/2018
• Supplement Dates Manufacturer Received: 09/24/2018
• Supplement Dates FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1