RECOVERY FILTER SYSTEM RF048F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-11-29 for RECOVERY FILTER SYSTEM RF048F manufactured by Bard Peripheral Vascular, Inc..

MAUDE Entry Details

Report Number2020394-2019-05082
MDR Report Key9391672
Report SourceCONSUMER
Date Received2019-11-29
Date of Report2019-11-29
Date Mfgr Received2019-11-01
Date Added to Maude2019-11-29
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 NameRECOVERY FILTER SYSTEM
Generic NameVENA CAVA FILTER
Product CodeDTK
Date Received2019-11-29
Catalog NumberRF048F
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 W 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-11-29

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