BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 18438105 · Received January 3, 2024

    Report

    Report Number
    2124215-2023-74492
    Event Type
    Injury
    Date Received
    January 3, 2024
    Date of Event
    December 8, 2023
    Report Date
    April 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF THIS INFLATABLE PENILE PROSTHESIS (IPP) IMAGES AT OUR QUALITY ASSURANCE LABORATORY, THE COMPONENTS UNDERWENT A THOROUGH ANALYSIS. THE PUMP WAS VISUALLY INSPECTED, AND LEAK TESTED. THE PUMP PASSED THE LEAKAGE TEST. THE OUTER LAYER OF THE PUMP BULB WAS WORN FROM WEAR AGAINST THE PUMP STRAIN RELIEF KINK RESISTANT TUBING (KRT) JUNCTION. THE PUMP KRT WAS WORN TO THE FILAMENT. THE KRT BETWEEN THE PUMP AND RESERVOIR WITH THE QUICK WINDOW CONNECT (QWC) HAD A COLLET MISSING FROM THE CONNECTOR END. THE KRT WAS TRIMMED DOWN TO THE QWC END, BUT THE TUBING WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION AVAILABLE AND ANALYSIS RESULTS, THE REPORTED DEVICE MECHANICAL ISSUE AND HOLE IN THE TUBING WERE UNABLE TO BE CONFIRMED; THEREFORE, THE CONCLUSION CODE OF CAUSE NOT ESTABLISHED HAS BEEN CHOSEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AS THE INFLATABLE PENILE PROSTHESIS DID NOT WORK AS EXPECTED. TWO WEEKS LATER, THE INFLATABLE PENILE PROSTHESIS PUMP WAS REMOVED AND REPLACED DUE TO A CRACK IN THE TUBING BETWEEN THE RESERVOIR AND PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS SEEN BY THE PHYSICIAN AS THE INFLATABLE PENILE PROSTHESIS DID NOT WORK AS EXPECTED. TWO WEEKS LATER, THE INFLATABLE PENILE PROSTHESIS PUMP WAS REMOVED AND REPLACED DUE TO A CRACK IN THE TUBING BETWEEN THE RESERVOIR AND PUMP. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549662 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION 72401110 811872009

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown Hospitalization| R