LMA PROTECTOR MEDICAL UNKNOWN

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 2019-10-10 for LMA PROTECTOR MEDICAL UNKNOWN manufactured by Teleflex Medical.

Event Text Entries

[182597418] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[182597419] Customer reported "unable to insert any air into cuff" during demonstration on a mannequin after initially inflating cuff. The device was inserted into the mannequin and the cuff pilot marker was in the red zone. The device was removed and another attempt made to insert air. The cuff would not inflate or deflate and the cuff pilot marker would not come back down.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681900-2019-00045
MDR Report Key9174805
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-10-10
Date of Report2019-09-23
Date of Event2019-09-19
Date Mfgr Received2019-11-06
Date Added to Maude2019-10-10
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
Generic NameLMA PROTECTOR
Product CodeCAE
Date Received2019-10-10
Catalog NumberMEDICAL UNKNOWN
Lot NumberUNKNOWN
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressATHLONE


Patients

Patient NumberTreatmentOutcomeDate
10 2019-10-10

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