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MAUDE MDR 2341631

MDR report key
2341631
Report number
MW5023102
Event key
0
Event type
3
Date of event
2010-10-27
Date received
2011-11-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TITANIUM MARKERMIJ Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-1101. O; 2. R

Event Narratives#

D

Patient 1

TITANIUM MARKERS WERE PLACED IN MY LEFT AND RIGHT BREASTS AFTER HAVING AN ULTRASOUND GUIDED BIOPSY. SOON AFTERWARD, I BEGAN EXPERIENCING SHARP, PIERCING RECURRING PAIN WHERE THE MARKERS WERE PLACED. THE PAIN HAS BECOME MORE INTENSE OVER TIME VS. SUBSIDING. I DID NOT EXPERIENCE ANY SORT OF BREAST PAIN PRIOR TO THIS PROCEDURE AT (B)(6). NO INFORMATION WAS PROVIDED PRIOR TO MARKER PLACEMENT IT WAS ORALLY PRESENTED AT THE END OF MY PROCEDURE AS SAFE, NON-ADVERSARIAL AND ROUTINE. THIS PRODUCT HAS BEEN LIFE CHANGING AS NOT A DAY GOES BY THAT I AM NOT IN PAIN.