BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS

    MDR report key: 3944563 · Received July 18, 2014

    Report

    Report Number
    2183959-2014-00310
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014 DURING THE IMPLANT OF AN IPP 700 INFLATABLE PENILE PROSTHESIS THE ACCESSORY KIT NEEDLE BROKE. IT WAS INDICATED THAT THE NEEDLE WAS INSERTED INTO THE FURLOW INSERTION TOOL AND THAT DURING INSERTION HALF OF THE NEEDLE PUSHED THROUGH THE GLANS OF THE PATIENT. IT WAS THEN DISCOVERED THAT THE NEEDLE WAS BROKEN. TO REMOVE THE OTHER HALF OF THE NEEDLE THE FURLOW INSERTION TOOL HAD TO BE REMOVED FROM THE PATIENT AND THE THREAD WAS PULLED IN A REVERSE MOTION TO REMOVE THE NEEDLE. ANOTHER NEEDLE (OF THE SAME TYPE) WAS USED FROM THE ACCESSORY KIT TO COMPLETE THE PROCEDURE; THE PATIENT WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT THE FURLOW INSERTION TOOL IS OWNED BY THE HOSPITAL. THE NEEDLE WAS DISPOSED AND IS NOT AVAILABLE FOR ANALYSIS. NO PATIENT COMPLICATIONS WERE REPORTED IN ASSOCIATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423878 AMS INFLATABLE PENILE PROSTHESIS DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R