FDA.reportPublic FDA data

MAUDE MDR 9860850

MDR report key
9860850
Report number
9612186-2020-00000
Event key
0
Event type
3
Date of event
2020-02-20
Date received
2020-03-20
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
PMS
Address
LINAC HOUSE FLEMING WAY CRAWLEY, WEST SUSSEX RH10 UK
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LEKSELL GAMMA KNIFE PERFEXIONSYSTEM, RADIATION THERAPY, RADIONUCLIDEELEKTA INSTRUMENT ABIWB6001Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-200

Event Narratives#

No narrative records found.