FDA.reportPublic FDA data

MAUDE MDR 8751054

MDR report key
8751054
Report number
1721279-2019-00115
Event key
0
Event type
3
Date of event
2019-05-22
Date received
2019-07-01
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 CORPORATIONMFA500-301500-301FGA18K05AY R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-07-0101. O

Event Narratives#

No narrative records found.