BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 8647925 · Received May 28, 2019

    Report

    Report Number
    2183959-2019-63505
    Event Type
    Injury
    Date Received
    May 28, 2019
    Date of Event
    May 7, 2019
    Report Date
    May 28, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REPLACEMENT SURGERY WITH HIS INFLATABLE PENILE PROSTHESIS (IPP) DUE TO AN ANEURYSM ON LEFT CYLINDER JUST DISTAL OF THE INPUT TUBE. THE IPP WAS EXPLANTED AND A NEW DEVICE CONSISTING OF A 21CMX12MM CYLINDERS, PUMP AND RESERVOIR WERE IMPLANTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439405 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION UNK-P-IPP

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R