BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMA IMPLANT

    MDR report key: 7313083 · Received March 1, 2018

    Report

    Report Number
    MW5075640
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    January 26, 2018
    Report Date
    February 28, 2018
    Manufacturer
    NATIONAL MEDICAL DEVICES INC.
    Product Code
    MIB
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    DR (B)(6) CLAIMS HE HAS A 501(K) CLEARING A PRODUCT FOR A PENILE IMPLANT. WHEN LOOKING UP HIS 510(K) #K042380. IT STATES IT'S FOR EARS NOSE AND THROAT. HE IS USING THIS APPROVAL TO SECURE TRUST IN PTS. IT'S ABSOLUTELY MEANINGLESS AND EXTREMELY MISLEADING. THIS PRODUCT THAT MR (B)(6) IS USING IS DESTROYING THE LIVES OF MANY MEN. HE IS PLAYING ON THEM, LYING ON THEM AND LEAVING THEM WITH A MESS TO DEAL WITH AFTERWARDS. MY HUSBAND IS PRETTY DISFIGURED FROM HIS PROCEDURE, AND IT IS INTERFERING WITH DAILY LIFE FUNCTIONS; DR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151788 PENUMA IMPLANT PENILE SILICONE BLOCK MIB NATIONAL MEDICAL DEVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other