BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8953182 · Received September 2, 2019

    Report

    Report Number
    2183959-2019-65927
    Event Type
    Injury
    Date Received
    September 2, 2019
    Date of Event
    April 3, 2019
    Report Date
    September 1, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INFLATION ISSUES WITH AN INFLATABLE PENILE PROSTHESIS (IPP). A REPLACEMENT SURGERY WAS PERFORMED. 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
    747655 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION UNK-P-IPP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R