FDA.reportPublic FDA data

MAUDE MDR 7071353

MDR report key
7071353
Report number
1831638-2017-00001
Event key
0
Event type
3
Date of event
2017-02-21
Date received
2017-11-30
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
BOWERMAN
Address
4488 CAMPUS DRIVE KALAMAZOO MI 49008 US
Phone
269-269-2695
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THERMO SCIENTIFIC TISSUE-LOC HISTOSCREENTHERMO SCIENTIFIC TISSUE-LOC HISTOSCREENRICHARD ALLAN SCIENTIFICIDZC-0250-GRN/A103710R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-3001. O

Event Narratives#

N

Patient 1

THERMO SCIENTIFIC? TISSUE-LOC? HISTOSCREEN? CASSETTES ARE USED FOR HANDLING SMALL BIOPSIES AND FRAGILE SPECIMENS. THE UNIQUE DESIGN PROVIDES AN INNER CHAMBER LINED WITH A "SEE-THROUGH" MESH FOR EASY IDENTIFICATION OF SPECIMENS. THEY ELIMINATE THE NEED FOR MESSY SPONGES OR LENS PAPERS. TISSUE-LOC HISTOSCREEN CASSETTES ARE AVAILABLE IN BULK PACKAGING AND IN TUBES INTENDED FOR HIGH THROUGHPUT PRINTING. THE CUSTOMER COMPLAINED THAT THE SCREEN ON THE TISSUE-LOC CASSETTE WAS DEFECTIVE. THIS CAUSED TISSUE TO BE LOST DURING PROCESSING.

D

Patient 1

THE CUSTOMER CLAIMED THAT THE SCREEN ON THE LID OF THE TISSUE-LOC CASSETTE WAS DEFECTIVE. THIS CAUSED TISSUE TO BE LOST DURING PROCESSING OF THE TISSUE AND THE PATIENT HAD TO BE REBIOPSIED.