FDA.reportPublic FDA data

MAUDE MDR 8154653

MDR report key
8154653
Report number
8154653
Event key
0
Event type
3
Date of event
2018-09-28
Date received
2018-12-12
Adverse event
0
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
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1WAGNER STERISETSTERILIZATION TRAYWAGNER GMBHFRG1.4404MDD 93/42/EWG* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-120

Event Narratives#

D

Patient 1

UPON COMPLETION OF A SURGERY IT WAS NOTED THAT THE CONDENSATE DRAIN VALVE FROM THE STERISET CONTAINER HAD BEEN MISSING SINCE THE STERILIZATION PROCESS. THIS WAS NOT DISCOVERED BECAUSE THE AUTOMATIC THERMOLOC SEALED SUCCESSFULLY AS NOTED BY THE RED BLOCKS. CURRENTLY THERE IS NO INDICATOR FOR WHEN THE VALVE IS MISSING OR EVEN IF THERE IS AN INSUFFICIENT SEAL.