FDA.reportPublic FDA data

MAUDE MDR 5299566

MDR report key
5299566
Report number
2024800-2015-00006
Event key
0
Event type
3
Date of event
2015-11-17
Date received
2015-12-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
RON DOMINGO
Address
10210 GENETIC CENTER DRIVE SAN DIEGO CA 92121 US
Phone
858-858-8584
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1APTIMA SPECIMEN COLLECTION KITIN-VITRO DIAGNOSTIC ASSAYHOLOGIC INCORPORATEDLSL301041-01N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-12-1501. R

Event Narratives#

D

Patient 1

AN INCIDENT AT (B)(4) OB-GYN OCCURRED WHILE A NURSE WAS COLLECTING SAMPLE FOR THE APTIMA COMBO 2 SWAB SPECIMEN COLLECTION KIT (PN: 301041-01). THE NURSE WAS HOLDING AN OPEN SWAB COLLECTION TUBE FOR THE DOCTOR. THE TUBE WAS HIT WITH HER HAND WHICH EJECTED MATERIAL FROM THE TUBE AND INTO HER EYE. THE APTIMA TUBE DID NOT CONTAIN ANY PATIENT SAMPLE. THE NURSE IMMEDIATELY FLUSHED HER EYES WITH WATER. IT WAS NOTED THAT HER EYE WAS RED AND IRRITATED AFTER IT WAS FLUSHED. A COPY OF THE SAFETY DATA SHEET WAS PROVIDED VIA THE HOLOGIC WEBSITE. THE NURSE WAS SEEN BY AN EYE DOCTOR WHO APPLIED ANTIBIOTIC OINTMENT AND PUT AN EYE PATCH ON THE NURSE FOR 24 HOURS. UPON FOLLOWING UP WITH THE CUSTOMER, SHE HAS INDICATED THAT HER EYE HAS CLEARED UP AND THERE ARE NO VISUAL INDICATION OF INJURY THAT REMAINS.