BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS HYDROFLEX PENILE PROSTHESIS

    MDR report key: 5587303 · Received April 19, 2016

    Report

    Report Number
    2183959-2016-00105
    Event Type
    Injury
    Date Received
    April 19, 2016
    Date of Event
    January 24, 1995
    Report Date
    August 5, 2020
    Manufacturer
    AMERICAN MEDICAL SYSTEMS
    Product Code
    FHW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5, F10. ORIGINALLY REPORTED IN 1995 ON REPORT NUMBER 2126326 1995 01061.

    Additional Manufacturer Narrative · 0

    CORRECTED: D2 COMMON DEVICE NAME FROM PENILE PROSTHESIS TO DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC. D2 PRODUCT CODE (FDA) FROM FAE TO FHW.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD HIS HYDROFLEX PENILE PROSTHESIS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS BECAUSE THE LEFT CYLINDER COULD NOT INFLATE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HIS HYDROFLEX PENILE PROSTHESIS REMOVED AND REPLACED WITH AN INFLATABLE PENILE PROSTHESIS BECAUSE THE LEFT CYLINDER COULD NOT INFLATE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242737 AMS HYDROFLEX PENILE PROSTHESIS DEVICE IMPOTENCE MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS 72400236 8601D

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R