FDA.reportPublic FDA data

MAUDE MDR 2120750

MDR report key
2120750
Report number
1061932-2011-00592
Event key
0
Event type
3
Date of event
2011-05-11
Date received
2011-06-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS NORA ZEROUNIAN
Address
250 S KRAEMER BOULEVARD BREA CA 92821 US
Phone
714-714-7149
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CYTO-STAT/CLONE (C-S) I3-RD1CYTO-STAT/CLONE (C-S) I3-RD1 REAGENTBECKMAN COULTER, INC.MVUN/A66043667354006FN Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-06-100

Event Narratives#

D

Patient 1

A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT, UPON RECEIVING, LIQUID WAS LEAKING FROM THE CYTO-STAT/CLONE (C-S) (B)(4). THE LIQUID ADHERED TO THE LABEL. THERE WAS NO DEATH OR INJURY TO THE OPERATOR AS A RESULT OF THIS INCIDENT. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES AND THE CUSTOMER DID NOT SEEK MEDICAL ATTENTION. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE): GLOVES, LAB COAT AND GOGGLES.

N

Patient 1

SERVICE WAS NOT DISPATCHED FOR THIS EVENT. NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER.