FDA.reportPublic FDA data

MAUDE MDR 1038736

MDR report key
1038736
Report number
1318354-2008-00001
Event key
0
Event type
3
Date of event
2008-03-27
Date received
2008-04-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Address
IDA BUSINESS PARK BRAY, CO. WICKLOW EI
Phone
353-353-3531
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TRINITY BIOTECH UNIGOLD RECOMBIGEN HIV CNTNONETRINITY BIOTECH PLC,MVW1206530R065001N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-04-230

Event Narratives#

D

Patient 1

IN 2008, TRINITY BIOTECH (TRINITY) TECHNICAL SERVICES RECEIVED A PHONE CALL FROM THE SUPERVISING NURSE OF FACE TO FACE'S SAFE ZONE. THEY HAD AN EXPOSURE INCIDENT INVOLVING A LABORATORY TECHNOLOGIST PERFORMING TESTING WITH THE TRINITY BIOTECH UNIGOLD RECOMBIGEN POSITIVE CONTROL. FACE TO FACE'S SAFE ZONE IS LOCATED AT 1 SUPPORT FACE TO FACE. THE TECHNOLOGIST WAS HANDLING THE POSITIVE CONTROL (KIT LOT NO. R065001, POSITIVE CONTROL LOT NO. R05108) WITHOUT WEARING GLOVES AND SOME OF THE FLUID SPLASHED ON HIS RIGHT HAND (FINGERTIP). THE TECHNOLOGIST FELT A ''BURNING SENSATION" AND RINSED WITH WATER, THEN USED AN ALCOHOL WIPE. IT WAS NOTED THERE WERE NO OPEN SORES OR CUTS ON HIS HAND. THE MEDS SHEET FOR THE PRODUCT WAS FAXED TO THE SITE FOR THEIR REVIEW. TRINITY HAS ALSO CONFIRMED THE POSITIVE MATERIAL USED TO MFR THE POSITIVE CONTROL HAS UNDERGONE CHEMICAL TREATMENT (1 BPUV (VIRUCIDAL AGENT) AND UV-IRRADIATION AND HAS BEEN CERTIFIED NEGATIVE AFTER A VIRUS CULTURE ASSAY. THE TECHNICIAN WAS FOLLOWED UP BY THE STAFF NURSE AND A BLOOD SAMPLE WAS DRAWN FOR BASELINE TESTING AND WILL BE SCHEDULED FOR FOLLOW UP TESTING TO OCCUR AT 3 TO 6 MONTHS.

N

Patient 1

TRINITY HAS CONFIRMED THE POSITIVE MATERIAL USED TO MFR THE POSITIVE CONTROL HAS UNDERGONE CHEMICAL TREATMENT (1 BPUV (VIRUCIDAL AGENT) AND UV-IRRADIATION AND HAS BEEN CERTIFIED NEGATIVE AFTER A VIRUS CULTURE ASSAY, THEREFORE, DEEM THE EXPOSURE RISK TO BE LOW. HOWEVER, IT SHOULD BE NOTED THE LAB TECH WAS USING THE PRODUCT OUTSIDE OF THE RECOMMENDED SAFE LABORATORY PRACTICES, AS HE WAS NOT WEARING GLOVES WHILE HANDLING THE MATERIAL.