AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE 72404130

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE 72404130 manufactured by Boston Scientific Corporation.

Event Text Entries

[188484012] 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.
Patient Sequence No: 1, Text Type: N, H10


[188484013] It was reported that patient called to express his dissatisfaction with his artificial urinary sphincter (aus). He states that it worked well initially and then he has started to experience progressive worsening of his incontinence. He states that now it is almost as bad as it was before he had the device. He has been told by his dr. That he needs to have a revision and he is refusing to pay. He doesn't think he should have to pay twice for a device that failed. He is pursuing that with the hospital and dr. Patient liaison explained him that the explanted device would be returned to bsc for analysis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183959-2020-01775
MDR Report Key9908122
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-16
Date Mfgr Received2020-03-16
Device Manufacturer Date2018-08-13
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 Number72404130
Catalog Number72404130
Lot Number1000147630
Device Expiration Date2019-08-13
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
10 2020-03-31

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