BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 5547005 · Received April 5, 2016

    Report

    Report Number
    2183959-2016-00097
    Event Type
    Injury
    Date Received
    April 5, 2016
    Date of Event
    March 24, 2016
    Report Date
    March 24, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE INFORMATION: CATALOG# 720185-01, SERIAL # (B)(4), EXPIRATION DATE 08/16/2014. DEVICE MANUFACTURE DATE: 09/2012.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME FROM PENILE PROSTHESIS TO DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC. (B)(4). PMA/510(K) FROM K821628 TO N970012.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED WHICH CLARIFIES THE EVENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD HIS INFLATABLE PENILE PROSTHESIS REPLACED AS THE DEVICE STOPPED WORKING DUE TO A LEAK IN THE SYSTEM AND A CYLINDER ANEURYSM. DURING THE REPLACEMENT SURGERY, THE PATIENT HAD "POOR VITAL O2 SATURATION" THAT DROPPED. THE PROCEDURE WAS STOPPED UNTIL THE PATIENT WAS STABLE AND THEN COMPLETED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT A "LEAK IN THE SYSTEM" DID NOT OCCUR WITH THE INFLATABLE PENILE PROSTHESIS AND THAT THE "POOR VITAL O2 SATURATION" WAS A RESULT OF THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204146 AMS INFLATABLE PENILE PROSTHESIS DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R