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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 72400025
Medical Device Problem Code Migration (4003)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/17/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that tubing connector had migrated up to just below skin level.The patient could feel the connector that was right below his skin; and the doctor was worried that the connector might eventually herniate out through the skin.Balloon was explanted and replaced.No adverse patient effects.
 
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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 Key10670358
Report Number2183959-2020-04614
Device Sequence Number16828740
Product Code EZY
UDI-Device Identifier00878953000633
UDI-Public00878953000633
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
P000053
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Expiration Date03/19/2025
Device Model Number72400025
Device Catalogue Number72400025
Device Lot Number1000416561
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/22/2020
Initial Report FDA Received Date10/13/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age64 YR
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