LMA SUPREME SIZE 3 175030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2019-11-26 for LMA SUPREME SIZE 3 175030 manufactured by Teleflex Medical.

Event Text Entries

[182597483] (b)(4).
Patient Sequence No: 1, Text Type: N, H10

[182597484] Complaint reported as: "found lma supreme gas tube leaking. " additional information was requested, but not received at the time of this report.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9681900-2019-00051
• MDR Report Key: 9378043
• Report Source: DISTRIBUTOR,FOREIGN,USER FACI
• Date Received: 2019-11-26
• Date of Report: 2019-11-11
• Date of Event: 2019-10-31
• Date Mfgr Received: 2019-11-11
• Date Added to Maude: 2019-11-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: VICTORIA SANDLIN
• Manufacturer Street: 3015 CARRINGTON MILL BLVD
• Manufacturer City: MORRISVILLE NC 27560
• Manufacturer Country: US
• Manufacturer Postal: 27560
• Manufacturer G1: THE LARYNGEAL MASK COMPANY
• Manufacturer Street: 6 BATTERY ROAD #07-02
• Manufacturer City: SINGAPORE 049909
• Manufacturer Country: SN
• Manufacturer Postal Code: 049909
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: LMA SUPREME SIZE 3
• Generic Name: LMA SUPREME
• Product Code: CAE
• Date Received: 2019-11-26
• Returned To Mfg: 2019-11-22
• Catalog Number: 175030
• Lot Number: PMAKVM
• Device Availability: R
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TELEFLEX MEDICAL
• Manufacturer Address: ATHLONE

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-11-26