DUALOK BREAST LESION LOCALIZATION WIRE LW0107

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-08-22 for DUALOK BREAST LESION LOCALIZATION WIRE LW0107 manufactured by Bard Peripheral Vascular, Inc..

Event Text Entries

[117957877] No medical records or no medical images have been made available to the manufacturer. As the lot number for the device was provided, a review of the device history records is currently being performed. The device has been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10


[117957878] It was reported that during an ultrasound-guided breast biopsy into normal tissue, the device allegedly failed to deploy and was difficult to remove from the patient. A tear in the patient's tissue occurred as a result of the removal of the device. It was further reported that a planned secondary intervention was performed and another device was used to complete the biopsy. The patient is stable.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2020394-2018-01528
MDR Report Key7807552
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2018-08-22
Date of Report2018-11-05
Date of Event2018-07-25
Date Mfgr Received2018-10-25
Device Manufacturer Date2018-04-26
Date Added to Maude2018-08-22
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 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 NameDUALOK BREAST LESION LOCALIZATION WIRE
Generic NameBIOPSY INSTRUMENT
Product CodeGDF
Date Received2018-08-22
Returned To Mfg2018-08-03
Catalog NumberLW0107
Lot NumberRECR0358
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBARD PERIPHERAL VASCULAR, INC.
Manufacturer Address1625 W 3RD ST. TEMPE AZ 85281 US 85281


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2018-08-22

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