FDA.reportPublic FDA data

MAUDE MDR 9391703

MDR report key
9391703
Report number
2183959-2019-67769
Event key
0
Event type
3
Date of event
2019-10-28
Date received
2019-11-29
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
ALYSON HARRIS
Address
10700 BREN ROAD W MINNETONKA MN 55343 US
Phone
408-408-4089
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONEDEVICE INCONTINENCE MECHANICAL/HYDRAULICBOSTON SCIENTIFIC CORPORATIONEZY7240413172404131736827010R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-11-2901. H; 2. R

Event Narratives#

No narrative records found.