BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 8104022 · Received November 26, 2018

    Report

    Report Number
    2183959-2018-61164
    Event Type
    Injury
    Date Received
    November 26, 2018
    Date of Event
    October 29, 2018
    Report Date
    November 26, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    UDI-DI
    00878953000725
    PMA / PMN Number
    P000053
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT COMPONENT: MODEL NUMBER/CATALOG NUMBER: 7240098 AND 72400024; SERIAL NUMBER: NULL AND NULL; BATCH/LOT NUMBER: 485199018 AND 484112008; MODEL/CATALOG DESCRIPTION: CONTROL PUMP FGS AND BALLOON FGS 61-70CM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRING INCONTINENCE WITH AN ARTIFICIAL URINARY SPHINCTER (AUS). THE AUS CUFF, PUMP, AND BALLOON WERE EXPLANTED AND A NEW AUS CUFF, PUMP, AND BALLOON WERE IMPLANTED. FURTHER INFORMATION WAS REQUESTED AND NOT YET RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941429 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION 72400161 483814008 00878953000725

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R