FDA.reportPublic FDA data

MAUDE MDR 3565155

MDR report key
3565155
Report number
1222780-2014-00006
Event key
0
Event type
3
Date of event
2013-01-01
Date received
2014-01-06
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
CHRISTINA PAUL
Address
250 CAMPUS DRIVE MARLBOROUGH MA 01752 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THINPREP IMAGING SYSTEMIMAGERHOLOGIC INC.MNMR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-01-060

Event Narratives#

D

Patient 1

NO DELAY IN PT DIAGNOSIS. CUSTOMER REPORTED THREE CASES OF SLIDES WITH DIAGNOSTIC CELLS OUTSIDE THE 22 FIELDS OF VIEW (FOV). THE THREE CASES WERE MANUALLY REVIEWED DUE TO ABNORMAL HISTORY. THE SUPERVISOR REPORTED SHE REVIEWED THE SLIDES AND THERE WERE NO ABNORMAL CELLS REPRESENTED IN THE 22 FOV. RARE ASCUS WAS FOUND ON MANUAL REVIEW. THE CUSTOMER WILL CONTINUE TO MONITOR BUT DID NOT WANT TO FOLLOW UP FURTHER AT THIS TIME.