BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 8647360 · Received May 28, 2019

    Report

    Report Number
    2183959-2019-63486
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    February 11, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953003580
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE BLOOD IN THE CYLINDER WAS NOT ASSOCIATED WITH ANY PATIENT INJURY OR SURGICAL COMPLICATION. THE IMPLANT PROCEDURE WAS PROLONGED MARGINALLY IN DURATION DUE TO THE ISSUE. ANOTHER DEVICE WAS IMPLANTED TO COMPLETE THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REPLACEMENT OF AN INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WHEN THE SURGEON DECIDED TO RE-POSITION THE DEVICE AND NOTICED BLOOD INSIDE THE CYLINDER. THE PHYSICIAN REPORTED THAT THE BLOOD IN THE CYLINDER INDICATED A DEFECT IN THE IMPLANT. THE IMPLANT WAS NOT USED. A PATIENT OUTCOME WAS NOT REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED AND IS NOT YET AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A REPLACEMENT OF AN INFLATABLE PENILE PROSTHESIS (IPP) DEVICE WHEN THE SURGEON DECIDED TO RE-POSITION THE DEVICE AND NOTICED BLOOD INSIDE THE CYLINDER. THE PHYSICIAN REPORTED THAT THE BLOOD IN THE CYLINDER INDICATED A DEFECT IN THE IMPLANT. THE IMPLANT WAS NOT USED. A PATIENT OUTCOME WAS NOT REPORTED. FURTHER INFORMATION HAS BEEN REQUESTED AND IS NOT YET AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439371 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72404250 1000134578 00878953003580

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O