ANTI-PAN KERATIN PRIMARY ANTIBODY, 25 ML 760-2135 05266840001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-03-06 for ANTI-PAN KERATIN PRIMARY ANTIBODY, 25 ML 760-2135 05266840001 manufactured by Ventana Medical Systems, Inc..

Event Text Entries

[16180429] Patient tissue tested at clinic was initially reported as negative, however, upon consult with another facility tissue reported positive.
Patient Sequence No: 1, Text Type: D, B5


[16346439] Requests for additional information and discussions with pathologist at clinic are ongoing. No reports of impact to patient care at this time.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2028492-2015-00001
MDR Report Key4584984
Report Source05,06
Date Received2015-03-06
Date of Report2015-02-05
Date of Event2014-11-17
Date Mfgr Received2015-02-05
Date Added to Maude2015-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactTIM GIBLIN
Manufacturer Street1910 EAST INNOVATION PARK DR.
Manufacturer CityTUCSON AZ 85755
Manufacturer CountryUS
Manufacturer Postal85755
Manufacturer Phone5208777035
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameANTI-PAN KERATIN PRIMARY ANTIBODY, 25 ML
Generic NamePAN CK
Product CodeNJT
Date Received2015-03-06
Model Number760-2135
Catalog Number05266840001
Lot NumberUNK
ID Number04015630971572
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVENTANA MEDICAL SYSTEMS, INC.
Manufacturer AddressTUCSON AZ US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2015-03-06

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