BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN INFLATABLE PENILE PROSTHESIS FAMILY

    MDR report key: 24551408 · Received March 9, 2026

    Report

    Report Number
    2125050-2026-00372
    Event Type
    Injury
    Date Received
    March 9, 2026
    Report Date
    March 9, 2026
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE ARTICLE REPORTED COMPLICATIONS FROM RESEARCH THAT OCCURRED IN THE UNITED STATES. COMPLICATIONS REPORTED WERE INFECTIONS. THE REPORTED COMPLICATIONS WERE IDENTIFIED IN THE RISK MANAGEMENT DOCUMENT AS POSSIBLE KNOWN HARM. COMPLAINTS WILL BE REVIEWED ROUTINELY TO MONITOR COMPLAINT TRENDS AS PART OF POST MARKET SURVEILLANCE. NO CORRECTIVE ACTION NO FURTHER INVESTIGATION REQUIRED AT THIS TIME. ARTICLE: TITLE- METHODS AND EARLY FINDINGS FROM A STUDY COMPARING NEXT-GENERATION SEQUENCING VERSUS TRADITIONAL CULTURES FOR PENILE IMPLANTS CONCERNING FOR LOW-GRADE INFECTION AUTHOR(S) - GERARD D. HENRY, NICCOLE DIAZ, CALEB D. PHILLIP, AARON C. LENT, PAUL PERITO, RICHARD NATALE, NELSON BENNETT, ANDREW R. STUART, CAROLINE J. HENRY, PAUL H. CHUNG DOI: 10.21037/TAU-2025-57.

    Description of Event or Problem · 0

    TITLE- METHODS AND EARLY FINDINGS FROM A STUDY COMPARING NEXT-GENERATION SEQUENCING VERSUS TRADITIONAL CULTURES FOR PENILE IMPLANTS CONCERNING FOR LOW-GRADE INFECTION. METHODS- STUDY SUBJECTS INCLUDED MALE PATIENTS AGED 18 TO 80 YEARS WHO HAD RECEIVED ANTIMICROBIAL TREATMENT FOR AT LEAST 7 DAYS WITHOUT SURGICAL REPLACEMENT FOR IPPS CONCERNING FOR LOW-GRADE INFECTION, OCCURRING WITHIN 6 MONTHS OF PENILE PROSTHESIS IMPLANTATION. TO DATE, OF THE 9 PATIENTS ENROLLED IN THE STUDY, 6 EVENTUALLY UNDERWENT DEVICE REMOVAL DUE TO WORSENING INFECTION WITHIN 7 DAYS OF INITIATING EMPIRIC ANTIBIOTIC TREATMENT. IN CASES WHERE PENILE SHAFT TENDERNESS WAS PRESENT, THE IMPLANTED IPP WAS MORE OFTEN REMOVED WITHIN 7 DAYS. IN CONTRAST, WHEN NO TENDERNESS WAS REPORTED, THE DEVICE REMAINED VIABLE FOR AT LEAST 10 DAYS. RECRUITMENT OF ADDITIONAL PATIENTS TO THIS PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL WILL HELP TO IDENTIFY FAVORABLE PRESENTATIONS OF IPP INFECTION. ADDITIONAL DATA WILL ALLOW COMPARISON OF IMPLANTATION OUTCOMES BETWEEN NGS AND TRADITIONAL CULTURE. ADDITIONAL ADVERSE EVENTS REFERENCED IN THE ARTICLE LINKED WITH THE INFECTION INCLUDED SWELLING, REDNESS, TENDERNESS, DRAIN OPENING TRACT, PUSS AND EXPOSED IPP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604276 TITAN INFLATABLE PENILE PROSTHESIS FAMILY PENILE PROSTHESIS, INFLATABLE FHW COLOPLAST A/S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention