BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMA

    MDR report key: 14653895 · Received June 9, 2022

    Report

    Report Number
    MW5110238
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    June 21, 2021
    Report Date
    June 7, 2022
    Manufacturer
    INTERNATIONAL MEDICAL DEVICES, INC.
    Product Code
    MIB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED THE PENUMA IMPLANT ON (B)(6) 2021 FROM DR. (B)(6). THE DEVICE CLAIMED TO BE THE FIRST FDA CLEARED PENILE IMPLANT AND THAT IT COULD SIMPLY BE REVERSED WITHOUT ANY MAJOR ISSUES. I FOLLOWED ALL THE PROPER PROTOCOL BUT STILL EXPERIENCED SKIN EROSION. ALSO THE DEVICE MAKER HAS MADE MANY MISLEADING STATEMENTS SAYING IT FEELS NATURAL WHICH IN MY EXPERIENCE IS ABSOLUTELY FALSE. ALSO IT IS NEVER BROUGHT TO ATTENTION THAT MESH IS ALSO INSERTED ALONG WITH THE SILICONE WHICH IS SUPPOSE TO CREATE SCAR TISSUE IN ORDER TO HELP SECURE THE DEVICE. THIS CREATES VARIOUS PROBLEMS WITH BLOOD CIRCULATION AND NERVES. AFTER FOLLOWING ALL THE PROPER PROTOCOL FOR 3 MONTHS PART OF THE EDGE OF THE DEVICE BEGAN TO CUT THROUGH THE SKIN AND I HAD IT REMOVED. ITS BEEN EIGHT MONTHS SINCE REMOVAL AND I HAVE NERVE DAMAGE WHICH CAUSES OCCASIONAL PAIN AND SENSITIVITY LOSS. I THINK THE WAY THIS DEVICE IS MARKETED IS EXTREMELY MISLEADING IN REGARDS TO SAFETY AND EFFECTIVENESS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1366430 PENUMA ELASTOMER, SILICONE BLOCK MIB INTERNATIONAL MEDICAL DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization