DAKOLINK TISSUE CASSETTES DL200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-06-12 for DAKOLINK TISSUE CASSETTES DL200 manufactured by Dako North America, Inc..

Event Text Entries

[16838182] Lip tissue sample was placed in tissue cassette for processing. The problem occurred during the formalin fixation step, which consists of the cassettes being placed in the retort chamber of the sakura vip5 tissue processor set at 45 degrees c with slight agitation under vacuum and pressure. Cassettes are set in racks that fit the chamber with nine cassettes per space, allowing room between cassettes for the reagent to flow freely. During this step, the cassette opened and the sample fell out. The sample could no longer be identified and no add'l tissue was available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2022180-2009-00002
MDR Report Key1403331
Report Source06
Date Received2009-06-12
Date of Report2009-06-05
Date of Event2009-05-28
Date Added to Maude2011-03-25
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 ContactKELLY MILLER
Manufacturer Street6392 VIA REAL
Manufacturer CityCARPINTERIA CA 93013
Manufacturer CountryUS
Manufacturer Postal93013
Manufacturer Phone8055666655
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameDAKOLINK TISSUE CASSETTES
Generic NameTISSUE CASSETTES
Product CodeIDZ
Date Received2009-06-12
Model NumberNA
Catalog NumberDL200
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerDAKO NORTH AMERICA, INC.
Manufacturer AddressCARPINTERIA CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2009-06-12

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