BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TACTRA MALLEABLE PENILE PROTHESIS

    MDR report key: 9467166 · Received December 13, 2019

    Report

    Report Number
    2183959-2019-68111
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 13, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAE
    PMA / PMN Number
    K183619
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION: THE COMPLAINT COMPONENT WAS NOT RETURNED FOR ANALYSIS, AND THE PRODUCT RECORD REVIEW REVEALED NO ADDITIONAL INFORMATION RELATED TO THE COMPLAINT SO AN OVERALL INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS CHOSEN AS THE REPORTED DEVICE PROBLEM CANNOT BE CONFIRMED. THE REPORTED ALLEGATIONS COULD NOT BE CONFIRMED. THE EVENT CANNOT BE REPRODUCED OR SUBSTANTIATED; THEREFORE, NO ESCALATION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE THIS TACTRA MALLEABLE PENILE PROSTHESIS (MPP) AS THEY WERE NOT SATISFIED WITH ITS CONCEALABILITY. THE MPP WAS REMOVED AND AN AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) WAS IMPLANTED IN ITS PLACE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1260794 TACTRA MALLEABLE PENILE PROTHESIS PROSTHESIS PENILE FAE BOSTON SCIENTIFIC CORPORATION UNK-P-TACTRA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R