BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONCEAL

    MDR report key: 22290538 · Received June 19, 2025

    Report

    Report Number
    2124215-2025-39532
    Event Type
    Injury
    Date Received
    June 19, 2025
    Date of Event
    May 27, 2025
    Report Date
    July 21, 2025
    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
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR LGX PRECONNECT TENACIO 18CM PS IZ IS (B)(4).

    Additional Manufacturer Narrative · 0

    UDI FIELD (D4) CONCOMITANT PRODUCT UDI FOR LGX PRECONNECT TENACIO 18CM PS IZ IS (B)(4).THERE WAS NO DEVICE AVAILABLE FOR ANALYSIS; THEREFORE, NO PHYSICAL OR VISUAL ANALYSIS OF THE PRODUCT COULD BE PERFORMED. THE REPORTED MIGRATION IS KNOWN RISKS ASSOCIATED WITH IMPLANTS 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

    IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS EXPERIENCED A CHOKING INCIDENT WHILE TAKING A PILL, WHICH LED TO COUGHING AND SUBSEQUENT HERNIATION OF THE RESERVOIR INTO THE SCROTUM. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE RESERVOIR HAD MIGRATED INTO THE SCROTUM. PRIOR TO THE MIGRATION, THE COMPONENT WAS LOCATED IN THE SPACE OF RETZIUS. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT WITH AN INFLATABLE PENILE PROSTHESIS IPP EXPERIENCED A CHOKING INCIDENT WHILE TAKING A PILL, WHICH LED TO COUGHING AND SUBSEQUENT HERNIATION OF THE RESERVOIR INTO THE SCROTUM. A REVISION SURGERY WAS PERFORMED, DURING WHICH THE PHYSICIAN CONFIRMED THAT THE RESERVOIR HAD MIGRATED INTO THE SCROTUM. PRIOR TO THE MIGRATION, THE COMPONENT WAS LOCATED IN THE SPACE OF RETZIUS. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1724267 CONCEAL PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION 720185-01 1100630966 00878953005669

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization| R LGX PRECONNECT LOT 1100534264, UPN 72404452.| LGX PRECONNECT LOT 1100534264, UPN 72404452.