FDA.reportPublic FDA data

MAUDE MDR 8946145

MDR report key
8946145
Report number
3005099803-2019-04227
Event key
0
Event type
3
Date of event
2017-06-14
Date received
2019-08-29
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
CAROLE MORLEY
Address
300 BOSTON SCIENTIFIC WAY MARLBOROUGH MA 01752 US
Phone
508-508-5086
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALAIRBRONCHIAL THERMOPLASTY SYSTEMBOSTON SCIENTIFIC CORPORATIONOOYM005ATS25010ATS 2-5R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-08-2901. H; 2. R

Event Narratives#

No narrative records found.