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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
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BOSTON SCIENTIFIC CORPORATION AMS 800 URINARY CONTROL SYSTEM; DEVICE INCONTINENCE MECHANICAL/HYDRAULIC Back to Search Results
Model Number 72400164
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event was unknown, used the first of the month it was reported.
 
Event or Problem Description
It was reported that the physician requested a surgical review of an artificial urinary sphincter (aus) due to an unspecified prosthesis defect.No information was provided about the patient's outcome.
 
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Brand Name
AMS 800 URINARY CONTROL SYSTEM
Common Device Name
DEVICE INCONTINENCE MECHANICAL/HYDRAULIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key11022709
Report Number2183959-2020-05953
Device Sequence Number3594545
Product Code EZY
UDI-Device Identifier00878953000756
UDI-Public00878953000756
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
P000053
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date05/05/2022
Device Model Number72400164
Device Catalogue Number72400164
Device Lot Number0173541013
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/08/2020
Initial Report FDA Received Date12/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age18 YR
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