FDA.reportPublic FDA data

MAUDE MDR 8772275

MDR report key
8772275
Report number
1721279-2019-00118
Event key
0
Event type
3
Date of event
2019-06-14
Date received
2019-07-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MISS CATHERINE EATON
Address
9965 FEDERAL DRIVE COLORADO SPRINGS CO 80921 US
Phone
719-719-7194
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SPECTRANETICS GLIDELIGHT LASER SHEATHGLIDELIGHTTHE SPECTRANETICS CORPORATIONMFA500-302500-302FGB19C13AY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-07-0901. O

Event Narratives#

No narrative records found.