LMA PROSEAL REU INTRODUCER (3, 4 & 5) 151030

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-01-02 for LMA PROSEAL REU INTRODUCER (3, 4 & 5) 151030 manufactured by Teleflex Medical.

Event Text Entries

[177666989] (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[177666990] Customer complaint alleges "the rubber on the end of the proseal introducer has become detached from the metal framework". The reported issue was found in preparation for use. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number9681900-2020-00001
MDR Report Key9538083
Report SourceFOREIGN,USER FACILITY
Date Received2020-01-02
Date of Report2019-12-10
Date of Event2019-12-10
Date Mfgr Received2020-02-03
Date Added to Maude2020-01-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 PROSEAL REU INTRODUCER (3, 4 & 5)
Generic NameAIRWAY,OROPHARYNGEAL,ANESTHESIOLOGY
Product CodeCAE
Date Received2020-01-02
Returned To Mfg2019-12-30
Catalog Number151030
Lot NumberUNKNOWN
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressATHLONE


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-02

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