MAUDE MDR 8824217

MDR report key
8824217
Report number
1423337-2019-00009
Event key
0
Event type
3
Date of event
2019-07-17
Date received
2019-07-24
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PELORIS RAPID TISSUE PROCESSORAUTOMATED TISSUE PROCESSORLEICA BIOSYSTEMS MELBOURNE PTY. LTDIEOPELORIS26.0005* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-07-2401. O

Event Narratives#

No narrative records found.