UNK VALEO

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for UNK VALEO manufactured by C.r. Bard, Inc. (gfo).

Event Text Entries

[185004988] As the lot number for the device was not provided, a manufacturing review could not be performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Patient Sequence No: 1, Text Type: N, H10


[185004989] It was reported that during treatment, the stent allegedly dislodged from the delivery system. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2020-02030
MDR Report Key9881117
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-25
Date of Report2020-03-25
Date Mfgr Received2020-02-27
Date Added to Maude2020-03-25
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 ContactJUDITH LUDWIG
Manufacturer Street1415 W. 3RD STREET
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1C.R. BARD, INC. (GFO)
Manufacturer Street289 BAY ROAD
Manufacturer CityQUEENSBURY NY 12804
Manufacturer CountryUS
Manufacturer Postal Code12804
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNK VALEO
Generic NameBALLOON EXPANDABLE STENT
Product CodeFGE
Date Received2020-03-25
Catalog NumberUNK VALEO
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerC.R. BARD, INC. (GFO)
Manufacturer Address289 BAY ROAD QUEENSBURY NY 12804 US 12804


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-25

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