BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEAL

    MDR report key: 23195840 · Received October 1, 2025

    Report

    Report Number
    2124215-2025-67460
    Event Type
    Injury
    Date Received
    October 1, 2025
    Date of Event
    August 1, 2025
    Report Date
    October 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR LGX PRECONNECT IS (B)(4). THE EXACT EVENT DATE WAS NOT AVAILABLE, THEREFORE THE DATE 08/01/2025 WAS USED AS AN ESTIMATE, BASED ON THE REPORTED ONSET OCCURRING IN AUG 2025. THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED ALLEGATIONS OF MIGRATION AND EROSION ARE KNOWN RISKS ASSOCIATED WITH IMPLANT OF THESE DEVICE AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). BASED ON THE INFORMATION AVAILABLE, A CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS ASSIGNED TO THIS INVESTIGATION.

    Description of Event or Problem · 0

    A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS (IPP) PRESENTED FOR A FOLLOW UP CONSULTATION AFTER THE DEVICE WAS IMPLANTED. DURING THE EXAMINATION, THE PHYSICIAN NOTED A HERNIATION OF THE RESERVOIR. THE PATIENT REPORTED BEING ABLE TO USE THE DEVICE WITHOUT ANY COMPLAINTS. A REVISION SURGERY WAS PERFORMED WITH THE INTENT TO REPOSITION THE RESERVOIR. HOWEVER, DURING SURGICAL PREPARATION, THE PHYSICIAN OBSERVED DISTAL EROSION OF THE LEFT CYLINDER; THEREFORE, IT WAS DECIDED TO REMOVE ALL COMPONENTS OF THE IPP AND IMPLANT A TACTRA MALLEABLE PROSTHESIS CYLINDER IN THE LEFT CORPORA CAVERNOSA. THE PHYSICIAN DECIDED TO SEND THE EXPLANTED DEVICE TO THE HOSPITAL'S LABORATORY FOR PATHOLOGY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292759 CONCEAL PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION 720185-01 1100741326

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention| H LGX LOT 1100706734, UPN 72404452.