BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 700 CX MS PUMP

    MDR report key: 21099070 · Received January 8, 2025

    Report

    Report Number
    2124215-2024-82937
    Event Type
    Injury
    Date Received
    January 8, 2025
    Date of Event
    December 1, 2024
    Report Date
    January 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCW
    UDI-DI
    00878953003443
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WITH THIS INFLATABLE PENILE PROSTHESIS REPORTED THAT HAD DEVELOPED AND DIAGNOSED WITH AN INGUINAL ABDOMINAL HERNIA. HE WAS TOLD BY THE PHYSICIAN THAT THE PROSTHESIS WAS WRAPPED AROUND HIS URETHRA AND BLADDER, AND THEY WOULD NOT DO THE SURGERY. THE PATIENT WANTED TO ASK IF HE SHOULD HAVE THE FUNCTIONAL DEVICE REMOVE AND REPLACED IF HE WOULD HAVE THE SURGERY. THE PATIENT SERVICE SPECIALIST SUGGESTED THE PATIENT TO DISCUSS WITH HIS PHYSICIAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869455 AMS 700 CX MS PUMP PROSTHESIS, PENIS, INFLATABLE JCW BOSTON SCIENTIFIC CORPORATION 72404231 876819005 00878953003443

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other REAR TIP EXTENDER: 72404325/821517016| RESERVOIR: 720185-01/919045004