BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 9914188 · Received April 1, 2020

    Report

    Report Number
    2183959-2020-01807
    Event Type
    Malfunction
    Date Received
    April 1, 2020
    Date of Event
    March 13, 2020
    Report Date
    April 1, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT INDICATED NOT FEELING PLEASED WITH AN INFLATABLE PENILE PROSTHESIS (IPP) AND WANTED TO HAVE IT REMOVED. 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
    373187 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION UNK-P-IPP

    Patients

    Seq Age Sex Outcome Treatment
    1