*

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-29 for * manufactured by *.

Event Text Entries

[6541782] Wire placed during needle localization was in incorrect place. Wire was pulled but a small fragment broke off and remained in the patient's breast. Information was shared with the patient and included in the post procedure note.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number4908432
MDR Report Key4908432
Date Received2015-05-29
Date of Report2015-05-29
Date of Event2015-01-30
Report Date2015-05-29
Date Reported to FDA2015-05-29
Date Reported to Mfgr2015-07-13
Date Added to Maude2015-07-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameGUIDEWIRE
Product CodeMIJ
Date Received2015-05-29
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorPHYSICIAN
Device AvailabilityN
Device Sequence No1
Device Event Key0
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
10 2015-05-29

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