BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 9587846 · Received January 14, 2020

    Report

    Report Number
    2183959-2020-00080
    Event Type
    Injury
    Date Received
    January 14, 2020
    Date of Event
    December 15, 2019
    Report Date
    March 5, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    UDI-DI
    00878953005669
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED THAT THE PATIENT WAS WELL. NO DEVICE WAS IMPLANTED AND THE PROCEDURE WAS ABORTED DURING THE PROCEDURE OF AN ORIGINAL IMPLANT. SYSTEM COMPONENTS: PRECONNECT DEVICE. MODEL- 72404232-10. LOT SN- (B)(6) . MFG DATE- 05/02/2019. EXP DATE- 05/01/2021. GTIN- (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE TO IMPLANT AN INFLATABLE PENILE PROSTHESIS(IPP) THE PATIENT'S VEIN WAS HIT AND BEGAN BLEEDING WHEN THE RESERVOIR WAS BEING IMPLANTED. THE ISSUE WAS RESOLVED AND THE DEVICE FUNCTIONED.

    Additional Manufacturer Narrative · 1

    SYSTEM COMPONENTS, PRECONNECT DEVICE, MODEL- 72404232-10, LOT SN- (B)(4), MFG DATE- 05/02/2019, EXP DATE- 05/01/2021, GTIN- (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO IMPLANT AN INFLATABLE PENILE PROSTHESIS(IPP) THE PATIENT'S VEIN WAS HIT AND BEGAN BLEEDING WHEN THE RESERVOIR WAS BEING IMPLANTED. THE ISSUE WAS RESOLVED AND THE DEVICE FUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50852 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 720185-01 1000346841 00878953005669

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| O