LMA PROTECTOR CUFF PILOT SIZE 3 192030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-30 for LMA PROTECTOR CUFF PILOT SIZE 3 192030 manufactured by Teleflex Medical.

Event Text Entries

[182598477] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[182598478] Customer complaint alleges "user was not able to deaerate from the cuff with a syringe during inflation test prior to use on a patient". The device was not used on the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681900-2019-00030
MDR Report Key8842399
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-07-30
Date of Report2019-06-12
Date of Event2019-06-12
Date Mfgr Received2019-10-04
Date Added to Maude2019-07-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKATHARINE TARPLEY
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194334854
Manufacturer G1THE LARYNGEAL MASK COMPANY
Manufacturer Street6 BATTERY ROAD #07-02
Manufacturer CitySINGAPORE 049909
Manufacturer CountrySN
Manufacturer Postal Code049909
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLMA PROTECTOR CUFF PILOT SIZE 3
Generic NameLMA PROTECTOR
Product CodeCAE
Date Received2019-07-30
Returned To Mfg2019-08-14
Catalog Number192030
Lot NumberMMBV8P
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressATHLONE


Patients

Patient NumberTreatmentOutcomeDate
10 2019-07-30

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