GHIATAS BREAST LOCALIZATION WIRE 475201

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 2019-07-30 for GHIATAS BREAST LOCALIZATION WIRE 475201 manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[152695315] The lot number of the device was provided. The device history records are currently under review. The device has been returned for evaluation. The photo review is currently underway review.
Patient Sequence No: 1, Text Type: N, H10


[152695316] It was reported that post placement of a localization wire, an artifact allegedly was found on mri imaging. Reportedly, the patient went to the or to remove the localization wire. It was further reported that there was no any additional intervention was required. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2019-02020
MDR Report Key8842928
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-07-30
Date of Report2019-07-30
Date of Event2019-07-08
Date Mfgr Received2019-07-08
Date Added to Maude2019-07-30
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 Street1625 W 3RD ST.
Manufacturer CityTEMPE AZ 85281
Manufacturer CountryUS
Manufacturer Postal85281
Manufacturer Phone4803032689
Manufacturer G1BARD REYNOSA S.A. DE C.V.
Manufacturer StreetBLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL
Manufacturer CityREYNOSA TAMAULIPAS 88780
Manufacturer CountryMX
Manufacturer Postal Code88780
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGHIATAS BREAST LOCALIZATION WIRE
Generic NameBIOPSY INSTRUMENT
Product CodeGDF
Date Received2019-07-30
Returned To Mfg2019-07-15
Model Number475201
Catalog Number475201
Lot NumberREDR2967
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 W 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2019-07-30

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