BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE

    MDR report key: 5722405 · Received June 14, 2016

    Report

    Report Number
    2183959-2016-00129
    Event Type
    Injury
    Date Received
    June 14, 2016
    Date of Event
    May 9, 2016
    Report Date
    May 25, 2016
    Manufacturer
    AMERICAN MEDICAL SYSTEMS (MN)
    Product Code
    JCW
    PMA / PMN Number
    N970012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION; ANALYSIS RESULTS INDICATE ONE CYLINDER AND THE RESERVOIR PERFORMED WITHIN SPECIFICATIONS. THE OTHER CYLINDER SUSTAINED A HOLE IN THE OUTER TUBE THAT APPEARS TO BE CAUSED BY A SHARP INSTRUMENT; THE CYLINDER REMAINED FUNCTIONAL. THE PUMP WAS NOT FUNCTIONALLY TESTED DUE CONTAMINATION BY WHAT APPEARS TO BE TISSUE.

    Additional Manufacturer Narrative · 1

    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 FOLLOWING THE IMPLANTATION OF HIS AMS 700 INFLATABLE PENILE PROSTHESIS, THE PATIENT EXPERIENCED INFECTION. "ONE MONTH POST-OP ((B)(6)), PATIENT PRESENTED WITH SCROTAL CELLULITIS AND RECEIVED 2 WEEKS OF AUGMENTIN. PATIENT SEEN IN SURGEON'S OFFICE FOR SCROTAL INCISION FLUCTUANCE. PATIENT RETURNED 2 DAYS LATER WITH OPEN INCISION AND DRAINED PURULENT FLUID, SCROTAL REDNESS, FIRMNESS, SCROTUM AND SUPRAPUBIC AREA PAIN WITH SYMPTOMATIC FEVER AND CHILLS. WBC COUNT 12,000. PATIENT WAS HOSPITALIZED AND RECEIVED BROAD-SPECTRUM IV ANTIBIOTICS FOR 72 HOURS. WHITE COUNT NORMALIZED AND CELLULITIS RESOLVED. PATIENT TAKEN TO SURGERY (B)(6) 2016 FOR SALVAGE, WASHOUT WITH REMOVAL OF PROSTHESIS AND WASHOUT AND PLACEMENT OF AN AMS MALLEABLE PROSTHESIS". PATIENT DID WELL POST-OP AND DISCHARGED TO HOME IN STABLE CONDITION. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN RELATION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379291 AMS INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC JCW AMERICAN MEDICAL SYSTEMS (MN)

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R