BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 3201375 · Received June 27, 2013

    Report

    Report Number
    2183959-2013-00911
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 26, 2012
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    FHW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L DEVICE INFO: RESERVOIR: CATALOG # 72404156, SERIAL #(B)(4), MFG: 03/2012, EXP: 03/01/2014. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE REGARDING THIS EVENT, IT WILL BE RE-EVALUATED AND A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD THE ENTIRE PENILE PROSTHESIS REMOVED AND REPLACED DUE TO DISTAL TIP EROSION ON THE LEFT SIDE. NO ADDITIONAL PT COMPLICATIONS HAVE BEEN REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294940 AMS INFLATABLE PENILE PROSTHESIS PENILE PROSTHESIS FHW AMERICAN MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R