BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMA IMPLANT

    MDR report key: 14675729 · Received June 10, 2022

    Report

    Report Number
    MW5110249
    Event Type
    Injury
    Date Received
    June 10, 2022
    Date of Event
    August 25, 2021
    Report Date
    June 8, 2022
    Manufacturer
    INTERNATIONAL MEDICAL DEVICES, INC.
    Product Code
    MIB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    GOT THE PENUMA IMPLANT. HAD TO BE HOSPITALIZED TO GET IT REMOVED TO PREVENT SERIOUS INFECTION DESPITE FOLLOWING POST OP INSTRUCTIONS TO A TEE. THE INSERTION, AND SUBSEQUENT REMOVAL HAVE CAUSED PAIN/NUMBNESS, IRREGULAR PENILE CURVATURE, LOSS OF PENILE LENGTH AND LOSS OF SEX DRIVE ALMOST 10 MONTHS POST OPERATION. IT WAS SUPPOSED TO BE "SAFE AND REVERSIBLE." I HAVE BEFORE AND AFTER PICTURES ON REDDIT, BUT THEY ARE NSFW. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1687676 PENUMA IMPLANT ELASTOMER, SILICONE BLOCK MIB INTERNATIONAL MEDICAL DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Male Disability| H| R BABY ASPIRIN| CENTRUM MULTIVITAMIN| RESTOREX PENILE TRACTION DEVICE