FDA.reportPublic FDA data

MAUDE MDR 9365879

MDR report key
9365879
Report number
1721279-2019-00205
Event key
0
Event type
3
Date of event
2019-11-05
Date received
2019-11-22
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
MRS. BARBARA CREEL
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 16F GLIDELIGHT LASER SHEATHGLIDELIGHTTHE SPECTRANETICS CORPORATIONMFA500-303500-303 N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2201. H; 2. L; 3. R

Event Narratives#

No narrative records found.