BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMA

    MDR report key: 15151342 · Received August 2, 2022

    Report

    Report Number
    3010606546-2022-00004
    Event Type
    Injury
    Date Received
    August 2, 2022
    Date of Event
    August 25, 2021
    Report Date
    August 2, 2022
    Manufacturer
    INTERNATIONAL MEDICAL DEVIES
    Product Code
    MIB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENTS ARE INSTRUCTED TO AVOID ANY SEXUAL STIMULATION FOR SEVERAL WEEKS FOLLOWING THE IMPLANTATION UNTIL CLEARED BY THE SURGEON. A SERIOUS INJURY REQUIRES A REMOVAL TO PREVENT AN INJURY OR ILLNESS THAT IS LIFE-THREATENING, RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, OR NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. INFECTION IS A POSSIBLE SERIOUS COMPLICATION WHICH COULD BE ASSOCIATED WITH THIS DEVICE AND IS MOST FREQUENTLY CAUSED BY SKIN CONTAMINANTS. SEPSIS CAN RESULT FROM INFECTION ANYWHERE IN THE BODY AND MAY DEVELOP WITH FEW OR NO SYMPTOMS. IT MAY OCCUR AS A RESULT OF A WOUND INFECTION. IN THE EVENT OF AN INFECTION, REMOVAL OF THE DEVICE MAY BE INDICATED IN ADDITION TO THE APPROPRIATE ANTIBIOTIC THERAPY. INFORMATION ON INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AND INFECTION IS LISTED AS A POTENTIAL ADVERSE REACTION AND COMPLICATION. AS THIS COMPLAINT WAS COMMUNICATED VIA A REVIEW OF THE MAUDE DATABASE, WITH INFORMATION REGARDING THE EXACT PRODUCT, LOT NUMBER, PATIENT, AND PHYSICIAN LEFT AS CONFIDENTIAL, IT IS NOT POSSIBLE TO REVIEW LOT RECORDS FOR THIS COMPLAINT. AN ARTICLE WAS PUBLISHED IN THE INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH (IJIR) TITLED UPDATE ON THE PENUMA AN FDA - CLEARED PENILE IMPLANT FOR AESTHETIC ENHANCEMENT OF THE FLACCID PENIS. THE ARTICLE DISCUSSES THE REMOVAL OF PENUMA IMPLANTS AND THAT ANY ADVERSE EVENTS FOLLOWING REMOVAL TEND TO SUBSIDE. A CLINICAL INVESTIGATION WAS IRB-APPROVED IN 2015, CLINICAL INVESTIGATION REPORT: RETROSPECTIVE ANALYSIS OF THE SAFETY AND EFFECTIVENESS OF THE SILICONE BLOCK IN PENILE SURGERY. THE 400 CONSENTED MEN AVERAGED 35.5 YEARS OF AGE WITH A MEAN BMI OF 25.4, JUST SLIGHTLY ABOVE THE NORMAL RANGE, AND WERE ALL CIRCUMCISED. 12/400 PATIENTS (3%) EXPERIENCED SERIOUS ADVERSE DEVICE EFFECTS NECESSITATING DEVICE REMOVAL. THE CAUSES INCLUDED IMPLANT BREAKAGE WITH IMPLANT PERFORATION AND INFECTION (4/400 PATIENTS (1%)); IMPLANT INFECTION (4/400 PATIENTS (1%)); SUTURE DETACHMENT (2/400 PATIENTS (0.5%)); IMPLANT BREAKAGE (1/400 (0.25%)); AND HEMATOMA (1/400(0.25%)). THE SELF-CONFIDENCE OPTIONS RANGED FROM 1 (LOW) TO 4 (VERY HIGH). POST-SURGERY, 83.5% OF RESPONDENTS (334/400) REPORTED AT LEAST A 2 CATEGORY IMPROVEMENT IN SELF-CONFIDENCE, AND LONG-TERM, 72.6% (223/307) REPORTED AT LEAST A 2 CATEGORY IMPROVEMENT IN SELF-CONFIDENCE (P <0.001 FOR BOTH). EIGHT-ONE PERCENT (81.0%) OF THE SUBJECTS REPORTED HIGH OR VERY HIGH LEVELS OF LONG-TERM SATISFACTION. RETROSPECTIVE ANALYSIS OF 400 SUBJECTS ELECTING SURGICAL CORRECTION OF PENILE DEFORMITIES DEMONSTRATED THE SAFETY AND EFFECTIVENESS OF SILICONE BLOCK. DEVICE REMOVALS ATTRIBUTED TO AN ADVERSE EVENT WERE RARE, AND SUBJECTS REPORTED IMPROVED SELF-CONFIDENCE AND HIGH LEVELS OF LONG-TERM SATISFACTION. THIS STUDY DEMONSTRATED THE SAFETY OF THE SILICONE BLOCK FOR ITS INTENDED USE. A REVIEW OF ALL PENUMA COMPLAINTS FROM 2014 THROUGH 2022 NOTED THAT SEVERAL COMPLAINTS MENTIONED INFECTION, MODERATE PAIN, AND DISSATISFACTION WITH COSMETIC RESULT, ALL OF WHICH ARE ALL ANTICIPATED SIDE EFFECTS. NONE OF THE REVIEWED COMPLAINTS ALLEGED IRREGULAR PENILE CURVATURE OR LOSS OF SEX DRIVE. 1 COMPLAINT IN 2018 ALLEGED "PERMANENT DISFIGUREMENT" WITHOUT FURTHER DETAILS, WHICH RESULTED IN IMD FILING AN MDR. 1 COMPLAINT FROM 2022 ALSO ALLEGED LOSS OF LENGTH WITHOUT FURTHER DETAILS, WHICH RESULTED IN IMD FILING AN MDR.

    Description of Event or Problem · 0

    EVENT WAS DISCOVERED THROUGH A REVIEW OF THE MAUDE DATABASE, SEE REPORT NUMBER MW5110249. PATIENT STATES THEY GOT THE PENUMA IMPLANT, AND SUBSEQUENTLY HAD TO BE HOSPITALIZED TO GET IT REMOVED TO PREVENT SERIOUS INFECTION DESPITE FOLLOWING POST OPERATIVE INSTRUCTIONS. PATIENT CLAIMS THE INSERTION AND SUBSEQUENT REMOVAL CAUSED PAIN/NUMBNESS, IRREGULAR PENILE CURVATURE, LOSS OF PENILE LENGTH, AND LOSS OF SEX DRIVE ALMOST 10 MONTHS POST OPERATION. ALL ALLEGED COMPLICATIONS ARE KNOWN AND REQUIRE PATIENT INFORMED CONSENT IN ADVANCE OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2064305 PENUMA PRE-FORMED PENILE SILICONE BLOCK MIB INTERNATIONAL MEDICAL DEVIES

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R