FDA.reportPublic FDA data

MAUDE MDR 2155713

MDR report key
2155713
Report number
9615030-2011-00003
Event key
0
Event type
3
Date of event
2011-06-24
Date received
2011-07-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
JUDY BRIMACOMBE
Address
5160, HACIENDA DRIVE DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1RADIATION SHIELDRADIATION SHIELDCARL ZEISS MEDITEC AGJAD304534-6000-585110851Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-07-0101. O

Event Narratives#

D

Patient 1

A NURSE REPORTED THAT WHILE A SURGICAL PROCEDURE (INTRAOPERATIVE RADIATION THERAPY FOLLOWING LUMPECTOMY) WAS IN PROCESS, SHE OBSERVED THAT THE INTRABEAM 20X20 CM STERILE SHIELD'S PACKAGING LOOKED WET INSIDE. SHE LATER DESCRIBED IT AS A "STICKY" LIQUID TYPE OF SUBSTANCE INSIDE THE STERILE PACKAGING. THIS PARTICULAR SHIELD WAS SET ASIDE AND ANOTHER ONE WITHIN THE SAME LOT WAS SELECTED, VISUALLY INSPECTED AND FOUND TO BE "NORMAL," AND WAS USED DURING SURGERY. THE SHIELDS AND/OR THE WOUND WAS CLEANED WITH TEGADERM AND BETADINE PRIOR TO PLACEMENT. THE SHIELDS WERE PLACED INSIDE THE WOUND AGAINST THE BREAST TISSUE.

N

Patient 1

THE SUSPECT PACKAGE WAS RETURNED FROM THE SITE TO (B)(4) FOR EVAL. RESULTS OF EVAL ARE NOT AVAILABLE YET.