FDA.reportPublic FDA data

MAUDE MDR 9908245

MDR report key
9908245
Report number
2183959-2020-01778
Event key
0
Event type
3
Date of event
2020-03-09
Date received
2020-03-31
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 SLING SYSTEMMESH SURGICAL FOR STRESS URINARY INCONTINENCE MALEBOSTON SCIENTIFIC CORPORATIONOTMUNK-P-SLING-MENSUNK-P-SLING-MENSR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-3101. H; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE PATIENT WAS UPGRADED FORM A SLING TO AN ARTIFICIAL URINARY SPHINCTER (AUS) DUE TO UNSPECIFIED REASON. NO INFORMATION ABOUT THE PATIENT'S OUTCOME WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED. THE PATIENT PRESENTED RECURRING INCONTINENCE. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED.