BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEAL

    MDR report key: 24889564 · Received April 15, 2026

    Report

    Report Number
    2124215-2026-20454
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    March 12, 2026
    Report Date
    April 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    UDI-DI
    00878953005669
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER: 72404252-10. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1000194480. MODEL/CATALOG DESCRIPTION: LGX PRECONNECT MS 18CM PS 10CM TL IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED DEVICE PERFORMANCE ALLEGATION CANNOT BE CONFIRMED. REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF INFLATION ISSUES, MIGRATION, AND FLUID LOSS WERE DEFINED IN THE PRODUCT RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS INFLATABLE PENILE PROSTHESIS (IPP) IMPLANT DEVICE WAS NO LONGER INFLATING. A SURGICAL PROCEDURE PERFORMED DURING WHICH THE ENTIRE DEVICE WAS EXPLANTED. UPON EXPLANT THE PHYSICIAN IDENTIFIED THAT THE RESERVOIR HAD MIGRATED TO THE SCROTUM WHEN PREVIOUSLY LOCATED IN THE SPACE OF RETZIUS, AND THERE WAS A FLUID LEAK AT THE RESERVOIR. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158693 CONCEAL PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION 720185-01 1000184603 00878953005669

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Hospitalization| R