BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 7982344 · Received October 18, 2018

    Report

    Report Number
    2183959-2018-60302
    Event Type
    Injury
    Date Received
    October 18, 2018
    Date of Event
    September 18, 2018
    Report Date
    October 18, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SAME CASE AS REPORT NUMBER: 2183959-2018-60288. IT WAS REPORTED THAT THE PATIENT HAD AN ARTIFICIAL URINARY SPHINCTER (AUS) AND INFLATABLE PENILE PROSTHESIS (IPP) REVISED DUE TO THE AUS PUMP AND IPP PUMP ENCAPSULATE TOGETHER CAUSING THE AUS PUMP TO BE DIFFICULT TO SQUEEZE. NO DEVICE WAS EXPLANTED THE AUS PUP WAS MOVED MORE LATERALLY IN THE SCROTUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822993 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R