BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 9845579 · Received March 17, 2020

    Report

    Report Number
    2183959-2020-01389
    Event Type
    Injury
    Date Received
    March 17, 2020
    Date of Event
    January 1, 2015
    Report Date
    March 17, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ARTIFICIAL URINARY SPHINCTER (AUS) REPLACEMENT SURGERY DUE TO UNSPECIFIED REASONS AROUND FIVE YEARS AGO. PRODUCT PERFORMANCE ANALYST (PPA) WAS UNABLE TO REQUEST FURTHER INFORMATION, AS CUSTOMER CONTACT FOR THE ACCOUNT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308378 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R