AMS 800 URINARY CONTROL SYSTEM UNK-P-AUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2019-11-30 for AMS 800 URINARY CONTROL SYSTEM UNK-P-AUS manufactured by Boston Scientific Corporation.

MAUDE Entry Details

Report Number2183959-2019-67788
MDR Report Key9392304
Report SourceFOREIGN,HEALTH PROFESSIONAL
Date Received2019-11-30
Date of Report2019-11-30
Date of Event2019-11-01
Date Mfgr Received2019-11-05
Date Added to Maude2019-11-30
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 Phone4089353452
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 Received2019-11-30
Model NumberUNK-P-AUS
Catalog NumberUNK-P-AUS
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 2019-11-30

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