AMS 800 URINARY CONTROL SYSTEM 72400160

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-27 for AMS 800 URINARY CONTROL SYSTEM 72400160 manufactured by Boston Scientific Corporation.

Event Text Entries

[188192251] It was reported that the patient underwent an artificial urinary sphincter (aus) replacement surgery due to unspecified reasons. During the procedure the existing device was removed and a new aus was implanted. No information was provided about the patient's outcome. It was further reported that the patient experienced recurring incontinence leading to the procedure. During the surgery urethral atrophy was noted at the cuff site. There were no device malfunctions associated with the explanted aus. The patient did not experience any further adverse events and was said to be good following the procedure. No more information available at the moment. Should additional information become available, it will be provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183959-2020-01669
MDR Report Key9891882
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-27
Date of Report2020-03-27
Date of Event2020-01-29
Date Mfgr Received2020-03-09
Device Manufacturer Date2007-03-30
Date Added to Maude2020-03-27
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactALYSON HARRIS
Manufacturer Street10700 BREN ROAD W
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal55343
Manufacturer Phone4083953452
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer Street10700 BREN ROAD W
Manufacturer CityMINNETONKA MN 55343
Manufacturer CountryUS
Manufacturer Postal Code55343
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMS 800 URINARY CONTROL SYSTEM
Generic NameDEVICE INCONTINENCE MECHANICAL/HYDRAULIC
Product CodeEZY
Date Received2020-03-27
Model Number72400160
Catalog Number72400160
Lot Number486679020
Device Expiration Date2012-03-13
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address10700 BREN ROAD W MINNETONKA MN 55343 US 55343


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2020-03-27

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