FDA.reportPublic FDA data

MAUDE MDR 9908128

MDR report key
9908128
Report number
2183959-2020-01767
Event key
0
Event type
3
Date of event
2020-03-12
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 800 URINARY CONTROL SYSTEMDEVICE INCONTINENCE MECHANICAL/HYDRAULICBOSTON SCIENTIFIC CORPORATIONEZYUNK-P-AUSUNK-P-AUSR N

Patients#

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

Event Narratives#

N

Patient 1

AS THE COMPLAINT COMPONENT WAS NOT RETURNED FOR ANALYSIS, AND THE PRODUCT RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT, THE REPORTED ALLEGATION COULD NOT BE CONFIRMED. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) PROCEDURE DUE TO RECURRING INCONTINENCE. AUS SYSTEM STOPPED CYCLING, LOSS OF PRESSURE IS PRESUMED. ALL COMPONENTS WERE REMOVED AND REPLACED WITH A NEW AUS SYSTEM. NO ADDITIONAL ADVERSE EFFECTS WERE REPORTED.