BRILLANT 2-W SILICONE FOLEY, TIEMANNBRILLANT 2 171305-000120

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-12 for BRILLANT 2-W SILICONE FOLEY, TIEMANNBRILLANT 2 171305-000120 manufactured by Teleflex Medical Sdn. Bhd..

Event Text Entries

[186331232] (b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10


[186331233] It was reported that for a (b)(6)-year-old patient, (b)(6) kg. There was leakage of the catheter. Happened with 4 patients. The product manager stated that it is not an incident due to the devices but an incident due to the age of the patients. Information was provided on (b)(6) 2020 to customer to inform about issues that can occur with old patients (bladder neck distends). The leakage would be due to an anatomic reason where the seal cannot be performed the same way for very old patients and younger patients. The opinion of the product managers was just provided as a simple opinion that would have may helped for the investigation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2020-00077
MDR Report Key9824012
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2020-03-12
Date of Report2020-02-24
Date of Event2020-02-17
Date Mfgr Received2020-02-24
Date Added to Maude2020-03-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactEFFIE JEFFERSON
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9194332672
Manufacturer G1TELEFLEX MEDICAL SDN. BHD.
Manufacturer StreetLOT NO : PT2577 JALEN PERUSAHAAN 4 KAMUNTING INDUSTRIAL ESTATE
Manufacturer CityPERAK, WEST MALAYSIA 34600
Manufacturer CountryMY
Manufacturer Postal Code34600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBRILLANT 2-W SILICONE FOLEY, TIEMANNBRILLANT 2
Product CodeEZL
Date Received2020-03-12
Catalog Number171305-000120
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL SDN. BHD.
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-12

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