BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 4220828 · Received November 3, 2014

    Report

    Report Number
    2183959-2014-00484
    Event Type
    Death
    Date Received
    November 3, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 8, 2014
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    FHW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESERVOIR CATALOG # 6/2/2014, LOT/SERIAL # (B)(4), EXPIRATION DATE 08/15/2016, MANUFACTURER DATE 09/2014.

    Additional Manufacturer Narrative · 1

    CORRECTED: COMMON DEVICE NAME FROM PENILE PROSTHESIS TO DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC. PRODUCT CODE (FDA) FROM FAE TO FHW. PMA/510(K) FROM K821628 TO N970012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH AND INFLATABLE PENILE PROSTHESIS AND HAD A SUPRAPUBIC FAT PAD REDUCTION ON (B)(6) 2014. THE PATIENT WENT FOR A FOLLOW UP APPOINTMENT 2 DAYS AFTER THE INITIAL IMPLANT. THE PHYSICIAN INDICATED THE PATIENT NEEDED TO MAKE SURE TO GET UP AND MOVE AROUND. THE PATIENT WENT HOME AND SEVERAL HOURS LATER WHILE WALKING AROUND SUFFERED A PULMONARY EMBOLISM. THE PATIENT WAS BROUGHT TO THE HOSPITAL BUT LATER DIED DUE TO THE PULMONARY EMBOLISM ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701600 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death