BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 22468846 · Received July 10, 2025

    Report

    Report Number
    2125050-2025-01121
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    August 11, 2018
    Report Date
    July 28, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE TITLED "ACUTE POST-INFLATABLE PENILE PROSTHESIS GLANS ISCHEMIA: REVIEW OF INCIDENCE, PATHOPHYSIOLOGY, AND MANAGEMENT RECOMMENDATIONS." KEVIN HEBERT, MD, AND TOBIAS S. KOHLER, MD, MPH. AS NO LOT# WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD, COMPLAINT HISTORY DATABASE, NONCONFORMANCE'S AND CAPAS COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLICATIONS WERE IDENTIFIED IN THE RISK MANAGEMENT DOCUMENT AS POSSIBLE KNOWN HARMS. COMPLAINTS WILL BE REVIEWED ROUTINELY TO MONITOR COMPLAINT TRENDS AS PART OF POST MARKET SURVEILLANCE. NO CORRECTIVE ACTION AND NO FURTHER INVESTIGATION REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    TITLE: ACUTE POST-INFLATABLE PENILE PROSTHESIS GLANS ISCHEMIA: REVIEW OF INCIDENCE, PATHOPHYSIOLOGY, AND MANAGEMENT RECOMMENDATIONS. CASE REPORT: IN OUR RECENT EXPERIENCE, WE PLACED A COLOPLAST TITAN 3-PIECE DEVICE (COLOPLAST CORP, MINNEAPOLIS, MN, USA) WITH 20-CM CYLINDERS BILATERALLY AND A RETROPUBIC CLOVERLEAF 75-ML RESERVOIR VIA A PENOSCROTAL INCISION. A 10-FRENCH (FR) BLAKE DRAIN WAS LEFT IN THE LEFT HEMI-SCROTUM. A 16-FR FOLEY CATHETER REMAINED AFTER SURGERY. THE DEVICE WAS LEFT INFLATED 60%-80%, AND THE PENIS WAS GENTLY WRAPPED WITH 4-INCH KERLIX GAUZE. WE WERE NOTIFIED 8 HOURS AFTER SURGERY ABOUT CONCERNS OF A DUSKY APPEARANCE TO THE GLANS. THIS WAS VERIFIED ON PHYSICAL EXAMINATION (FIGURE 1A). WE IMMEDIATELY PERFORMED THE PREVIOUSLY DESCRIBED MEASURES WITH REMOVAL OF THE FOLEY CATHETER, DEVICE DEFLATION, AND REMOVAL OF THE KERLIX GAUZE. IMMEDIATE IMPROVEMENT IN GLANS COLORATION WAS NOT SEEN. BECAUSE OF EARLY IDENTIFICATION, WE ELECTED TO PERFORM SERIAL EXAMINATIONS OVERNIGHT WITH THE UNDERSTANDING THAT IF SIGNIFICANT IMPROVEMENT IN GLANS COLORATION WAS NOT SEEN BY EARLY MORNING, DEVICE EXPLANATION WOULD BE PERFORMED. TRANSPARENCY WITH THE PATIENT AT THE TIME OF DIAGNOSIS IS INTEGRAL AND, IN THIS CASE, PREPARED THE PATIENT FOR SURGICAL INTERVENTION. AT 17 HOURS AFTER SURGERY (5 AM POSTOPERATIVE DAY [POD] 1), ISCHEMIA PERSISTED (FIGURE 1B). WE ADVISED DEVICE REMOVAL WITH CAREFUL DISCUSSION OF THE RISK OF TISSUE LOSS DESPITE DEVICE REMOVAL. THIS CASE WAS FURTHER COMPLICATED BY THE FACT THAT OUR PATIENT WAS FULLY ANTICOAGULATED WITH THERAPEUTIC HEPARIN, CLOPIDOGREL (PLAVIX), AND ASPIRIN BECAUSE OF HIS EXTENSIVE CARDIAC HISTORY. ALL COMPONENTS WERE SUCCESSFULLY REMOVED, AND THE PREVIOUS CORPOROTOMY SITES WERE CLOSED IN WATERTIGHT FASHION. DURING SURGERY, THE SCROTAL TISSUE WAS REMARKABLY FRIABLE AND HEMORRHAGIC. RETURN OF GLANS COLORATION OCCURRED SLOWLY AS DISPLAYED AT PODS 1, 3, 9, AND 21 AFTER EXPLANTATION (FIGURE 1CEF). AFTER SURGERY, NO TISSUE LOSS OCCURRED, AND THE PATIENT¿S TEMPORARY VOIDING ISSUES RESOLVED. ADDITIONAL PATIENT EFFECTS REPORTED IN THE CASE STUDY INCLUDED: BLEEDING POST DEVICE REMOVAL REQUIRING 4 UNITS OF BLOOD TO BE TRANSFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    793147 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Unknown Required Intervention