BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIMPLANT BY PENUMA

    MDR report key: 17515405 · Received August 11, 2023

    Report

    Report Number
    3010606546-2023-00022
    Event Type
    Injury
    Date Received
    August 11, 2023
    Date of Event
    November 12, 2018
    Report Date
    August 11, 2023
    Manufacturer
    INTERNATIONAL MEDICAL DEVICES
    Product Code
    MIB
    UDI-DI
    B097IMD006LLO1
    PMA / PMN Number
    K042380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT COMPLAINED OF MODERATE SWELLING AND DISSATISFACTION WITH AESTHETIC RESULT. AS PART OF THE INFORMED CONSENT PROCESS, THE PATIENT SIGNED OFF ON VARIOUS RISKS AND COMPLICATIONS ONE-BY-ONE. THE RELEVANT RISKS SIGNED OFF BY THE PATIENT INCLUDE PATIENT OR PARTNER DISSATISFACTION WITH FIRMNESS, SIZE (LENGTH AND/OR GIRTH) OF ERECTION AND SWELLING. ON(B)(6) 2018, THE PATIENT COMPLAINED OF SWELLING. HE HAD NOT HAD ANY PREVIOUS FOLLOW-UPS DESPITE POST-OPERATIVE CARE INSTRUCTIONS. HE ALSO REPORTED HE HAD NOT BEEN USING TUBI-HEAL FOR SEVERAL WEEKS AND WAS REMINDED TO WEAR IT. HE DID NOT FOLLOW-UP FURTHER DESPITE BEING CONTACTED BY THE SURGEON'S OFFICE FOR UPDATES. THE INSTRUCTIONS FOR USE (IFU), WHICH WERE REVIEWED AS PART OF THE 510(K) PROCESS, IDENTIFY DISSATISFACTION WITH COSMETIC RESULTS AS A POTENTIAL COMPLICATION, WHICH IS COMMUNICATED TO THE PATIENT PRIOR TO IMPLANTATION. AS A PART OF THE INFORMED CONSENT PROCESS, PATIENTS ARE MADE AWARE OF POST-OPERATIVE INSTRUCTIONS. THE PATIENT ACKNOWLEDGED AND AGREED TO THE FOLLOWING STATEMENTS: "I WILL FOLLOW ALL GIVEN POST-OPERATIVE INSTRUCTIONS; I WILL APPEAR ON DAYS 1,2,3 AND 4 IMMEDIATELY AFTER SURGERY FOR SCHEDULED FOLLOW-UPS; I WILL APPEAR AT LEAST ONCE WEEKLY FOR FOLLOW-UP APPOINTMENTS (IN PERSON OR VIA EMAIL) FOR AT LEAST 8 WEEKS AFTER SURGERY; I UNDERSTAND THAT I WILL NEED TO WRAP MY PENIS USING THE TUBIGRIP COMPRESSION SOCK DURING THE DAY AND REMOVE IT AT NIGHT FOR APPROXIMATELY 8 WEEKS AFTER MY PROCEDURE OR UNTIL TOLD OTHERWISE BY THE SURGEON. THE TUBIGRIP COMPRESSION SOCK IS WORN TO ASSIST WITH POST-OPERATION SWELLING. THE PATIENT DID NOT COMPLY TO ANY OF THESE STATEMENTS, THUS FAILING TO FOLLOW POST-OPERATIVE INSTRUCTIONS.

    Description of Event or Problem · 0

    PATIENT COMPLAINED OF MODERATE SWELLING AND DISSATISFACTION WITH COSMETIC RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868545 HIMPLANT BY PENUMA PRE-FORMED PENILE SILICONE BLOCK MIB INTERNATIONAL MEDICAL DEVICES 40209-007 877155 B097IMD006LLO1

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male Other