BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 800 URINARY CONTROL SYSTEM

    MDR report key: 17351950 · Received July 19, 2023

    Report

    Report Number
    2124215-2023-38148
    Event Type
    Injury
    Date Received
    July 19, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 19, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED PATIENT SYMPTOMS ARE A KNOWN RISK ASSOCIATED WITH IMPLANT OF THESE DEVICE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT HAD AN ARTIFICIAL URINARY SPHINCTER AND INFLATABLE PENILE PROSTHESIS. THE HOSPITAL SHOVED A CATHETER THROUGH THE PATIENT'S AUS UNKNOWINGLY RESULTING IN EROSION IN THE BULBOUS URETHRA AND THE EROSION LED TO AN INFECTION. A SURGICAL PROCEDURE WAS PERFORMED DURING WHICH THE AUS AND IPP WERE REMOVED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED. LATER, ONLY THE AUS WAS REIMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37616 AMS 800 URINARY CONTROL SYSTEM DEVICE INCONTINENCE MECHANICAL/HYDRAULIC EZY BOSTON SCIENTIFIC CORPORATION UNK-P-AUS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| R