METAL MARKER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-03-13 for METAL MARKER manufactured by .

Event Text Entries

[22094394] My doctor inserted a marker in my breast after a stereotactic breast biopsy. I have had intense itching and pain at the site and i think the marker has moved.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5019791
MDR Report Key2021684
Date Received2011-03-13
Date of Report2011-03-13
Date of Event2010-08-01
Date Added to Maude2011-03-21
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Generic NameMETAL MARKER
Product CodeMIJ
Date Received2011-03-13
Device AvailabilityY
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2011-03-13

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