FDA.reportPublic FDA data

MAUDE MDR 9621565

MDR report key
9621565
Report number
9616031-2020-00003
Event key
0
Event type
3
Date of event
2019-07-11
Date received
2020-01-23
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
MR. DENNIS GENITO
Address
LJUNGADALSGATAN 11 VAXJO US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
188-SERIESDISINFECTOR, MEDICAL DEVICESGETINGE DISINFECTION ABMEC88-5N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-230

Event Narratives#

No narrative records found.