BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE

    MDR report key: 8121741 · Received November 30, 2018

    Report

    Report Number
    2183959-2018-61290
    Event Type
    Injury
    Date Received
    November 30, 2018
    Date of Event
    November 2, 2018
    Report Date
    April 12, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953005652
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER 72400024. SERIAL NUMBER (B)(4). BATCH/LOT NUMBER 187110008. MODEL/CATALOG DESCRIPTION BALLOON, FGS. MODEL NUMBER/CATALOG NUMBER 72404127. SERIAL NUMBER (B)(4). BATCH/LOT NUMBER 188534004. MODEL/CATALOG DESCRIPTION CONTROL PUMP WITH IZ. ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER REMOVED DUE TO EROSION. THE PATIENT WENT TO THE ER AFTER AN ACCIDENT. IN THE ER, THEY PUT IN A CATHETER WAS CAUSED EROSION. A NEW ARTIFICIAL URINARY SPHINCTER CONSISTING OF A 4.O CM CUFF, PUMP, AND BALLOON WAS IMPLANTED LATER ON (B)(6) 2018. ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION AND RECURRING INCONTINENCE.

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER 72400024, SERIAL NUMBER (B)(4), BATCH/LOT NUMBER 187110008, MODEL/CATALOG DESCRIPTION BALLOON, FGS. MODEL NUMBER/CATALOG NUMBER 72404127, SERIAL NUMBER (B)(4), BATCH/LOT NUMBER 188534004, MODEL/CATALOG DESCRIPTION CONTROL PUMP WITH IZ.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THE ARTIFICIAL URINARY SPHINCTER REMOVED DUE TO EROSION. THE PATIENT WENT TO THE ER AFTER AN ACCIDENT. IN THE EMERGENCY ROOM (ER), THEY PUT IN A CATHETER WAS CAUSED EROSION. A NEW ARTIFICIAL URINARY SPHINCTER CONSISTING OF A 4.O CM CUFF, PUMP, AND BALLOON WAS IMPLANTED LATER ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959081 AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 720157-01 0162356014 00878953005652

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R