BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 9440626 · Received December 9, 2019

    Report

    Report Number
    2183959-2019-68010
    Event Type
    Injury
    Date Received
    December 9, 2019
    Date of Event
    December 2, 2019
    Report Date
    December 9, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO A LACK OF RIGIDITY THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS LGX(IPP) REMOVED AND REPLACED INFLATABLE PENILE PROSTHESIS CX. THE IPP LGX WAS EXPLANTED AND A NEW IPP CX CONSISTING OF A 21CMX12MM CYLINDERS AND PUMP. IT WAS EXPLAINED THAT THAT IPP LGX WAS WORKING CORRECTLY. THE PATIENT IS DOING WELL AFTER THIS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235994 AMS INFLATABLE PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW BOSTON SCIENTIFIC CORPORATION UNK-P-IPP

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R