BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEAL

    MDR report key: 24594539 · Received March 13, 2026

    Report

    Report Number
    2124215-2026-14134
    Event Type
    Injury
    Date Received
    March 13, 2026
    Date of Event
    December 12, 2025
    Report Date
    March 13, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    UDI-DI
    00878953005669
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER/CATALOG NUMBER: 72404257. SERIAL NUMBER: N/A. BATCH/LOT NUMBER: 1100411289. MODEL/CATALOG DESCRIPTION: LGX PRECONNECT MS 18CM IP IZ. UNIQUE IDENTIFIER (UDI) #: (B)(4). THE DEVICE IS NOT AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THERE WAS NO REPORT OF A DEVICE PERFORMANCE ALLEGATION. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE DEVICE INSTRUCTIONS FOR USE (IFU) WAS COMPLETED AND DID NOT REVEAL ANY EVIDENCE OF DEVICE MISUSE, OFF LABEL USE, OR FAILURE TO FOLLOW INSTRUCTIONS. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF PATIENT PROBLEM/MEDICAL PROBLEM AND HERNIA 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 THE INFORMATION AVAILABLE, A CONCLUSION CODE OF ADVERSE EVENT RELATED TO PATIENT CONDITION WAS CHOSEN AS THE ALLEGATION RELATES THE SYMPTOMS OF HERNIA NOT BEING RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS (IPP) HAD A HERNIA AT THE RESERVOIR LOCATION. A SURGICAL PROCEDURE WAS PERFORMED IN WHICH THE RESERVOIR WAS REPOSITIONED. THERE WERE NO FURTHER PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654125 CONCEAL PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION 720185-01 1100466706 00878953005669

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Hospitalization| R