BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMS 700 INFLATABLE PENILE PROSTHESIS

    MDR report key: 1650750 · Received April 2, 2010

    Report

    Report Number
    2183959-2010-00187
    Event Type
    Injury
    Date Received
    April 2, 2010
    Date of Event
    November 27, 2007
    Report Date
    December 1, 2009
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    JCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FREQUENCY OF OCCURRENCE OF THE EVENT IS ADDRESSED IN THE DEVICE LABELING. THE FREQUENCY FOR THIS EVENT IS NOT GREATER THAN IS USUAL.

    Description of Event or Problem · 1

    INFO RECEIVED ON 12/14/2007 INDICATES A (B) (6) MALE WITH PEYRONIE'S DISEASE AND POST PROSTATECTOMY WAS IMPLANTED WITH AN IPP DEVICE ON (B) (6) 2007. THE DOCTOR ATTEMPTED TO INFLATE THE CYLINDERS, WHEN THE CYLINDERS DID NOT INFLATE AT THE END OF THE PROCEDURE, IT WAS DUE TO "URETHRAL EXCURSION" AND THE CYLINDERS WERE REMOVED AND THE PUMP WAS PLUGGED WITH THE RESERVOIR ATTACHED (DEACTIVATED AND LEFT IN PLACE). NO CYLINDERS WERE LEFT IN THE PT. ON (B) (6) 2009, PT ALLEGED THE PENILE IMPLANT RUPTURED FOLLOWING THIS SURGERY ON (B) (6) 2007. ADDITIONAL INFO RECEIVED ON 04/01/2010 INDICATES THE PT ALLEGES UPON INSERTING THE PENILE IMPLANT, DOCTOR ACTIVATED THE PUMP TO TEST THE DEVICE TO MAKE SURE IT WOULD OPERATE. UPON ACTIVATING THE PUMP, THE DEVICE RUPTURED AND CAUSED SERIOUS AND PERMANENT INJURIES, INCLUDING EXCESSIVE BLEEDING FROM THE GROIN AREA, SEVERE PAIN IN THE GROIN AREA, PERMANENT DISFIGUREMENT, AND PERMANENT LOSS OF USE. NO FURTHER INFO PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMS 700 INFLATABLE PENILE PROSTHESIS INFLATABLE PENILE PROSTHESIS JCW AMERICAN MEDICAL SYSTEMS, INC. IPP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R| S