PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES 02J27-011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2012-02-09 for PROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES 02J27-011 manufactured by Abbott Molecular, Inc..

Event Text Entries

[19227917] The probechek urovysion control slides are non-hybridized slides prepared with cultured normal male lymphoblast cells and cultured bladder cancer cell lines. Each control slide consists of two separate target areas in which each of the different cell types have been applied. The cell lines are harvested, fixed in suspension medium, and applied to the glass microscope slides in a method optimal for fish (fluorescence in situ hybridization). A customer reported that one of the three slides in a probechek urovysion bladder kit control slides package was broken. There was no damage to the exterior shipping box. There were no injuries reported.
Patient Sequence No: 1, Text Type: D, B5


[19472818] The following narrative is contained in the product package insert: "the probechek controls and all other fresh or fixed specimens should be handled as if capable of transmitting infectious agents. Dispose of with proper precautions. Because it is often impossible to know which might be infectious, all specimens are to be treated with universal precautions. Guidelines for specimen handling are available from the u. S. Centers for disease control and prevention. Material safety data sheets (msds) on all materials supplied in the probechek controls are available from the abbott molecular technical service department. Avoid contact of probechek slides with skin and mucous membranes. "
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005248192-2012-00008
MDR Report Key2708758
Report Source07
Date Received2012-02-09
Date of Report2012-01-18
Date of Event2012-01-18
Date Mfgr Received2012-01-18
Date Added to Maude2012-08-27
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 ContactMR. DIMITRIS DEMIRTZOGLOU
Manufacturer Street1300 E. TOUHY AVE.
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal60018
Manufacturer Phone2243617975
Manufacturer G1ABBOTT MOLECULAR, INC.
Manufacturer Street1300 E. TOUHY AVE.
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal Code60018
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROBECHEK UROVYSION BLADDER CANCER KIT CONTROL SLIDES
Generic NameMICROSCOPIC CONTROL SLIDES USED IN FISH TESTING
Product CodeMMW
Date Received2012-02-09
Catalog Number02J27-011
Lot Number435929
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MOLECULAR, INC.
Manufacturer Address1300 E. TOUHY AVE. DES PLAINES IL 60018 US 60018


Patients

Patient NumberTreatmentOutcomeDate
10 2012-02-09

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