AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE 720157-01

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 2020-03-31 for AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE 720157-01 manufactured by Boston Scientific Corporation.

Event Text Entries

[185914159] 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. Related components of device system: model number/ catalog number: 72404127, serial number: n/a, batch/ lot number: 0147811018. Model/ catalog description: control pump fgs iz. Model number/ catalog number: 72400024, serial number: n/a, batch/ lot number: 0147781017, model/ catalog description: balloon fgs 61-70 cm.
Patient Sequence No: 1, Text Type: N, H10


[185914160] It was reported that the patient experienced recurring incontinence due to urethral atrophy at the cuff site of his artificial urinary sphincter (aus). All components were removed and replaced with a new aus system. The patient had a good outcome with no further complication. Additional information received. The explanted 3. 5 cm cuff was replaced with a 4. 5 cm cuff. The previous cuff was the correct size and was placed in the correct location.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183959-2020-01784
MDR Report Key9908357
Report SourceHEALTH PROFESSIONAL
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-16
Date Mfgr Received2020-03-16
Device Manufacturer Date2016-07-14
Date Added to Maude2020-03-31
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 WITH INHIBIZONE
Generic NameDEVICE INCONTINENCE MECHANICAL/HYDRAULIC
Product CodeEZY
Date Received2020-03-31
Model Number720157-01
Catalog Number720157-01
Lot Number0141976003
Device Expiration Date2017-07-14
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 2020-03-31

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