BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 77940 · Received March 25, 1997

    Report

    Report Number
    2125050-1997-00143
    Event Type
    Injury
    Date Received
    March 25, 1997
    Date of Event
    February 11, 1997
    Report Date
    March 25, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 9/19/96 AND REVISED ON 2/11/97 BECAUSE THE RESERVOIR WAS "BELIEVED TO HAVE A LEAK, ONCE REMOVED NO LEAK FOUND." A RESERVOIR WAS RETURNED FOR EVALUATION. REQUESTS FOR ADD'L INFO SURROUNDING THIS EVENT HAS BEEN MADE, HOWEVER, TO DATE THE INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THIS INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL REEVALUATE TH IS EVENT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED COMPONENT REVEALED NO FUNCTIONAL ABNORMALITIES. BECAUSE TESTING DID NOT REVEAL ANY FUNCTIONAL ABNORMALITIES, QA CONCLUDED THAT NO FUNCTIONAL ABNORMALTIES CONTRIBUTED TO THE REPORTED EVENT. BECAUSE THE INFO PROVIDED WAS LIMITED AND DID NOT INDICATE WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS OCCURRENCE, QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED AS THE "RESERVOIR BELIEVED TO HAVE A LEAK". AS REPORTED TO CO, THE RESERVOIR AND SOME ASSEMBLY KIT COMPONENT ONLY WERE REMOVED AND REPLACED: LEAVING THE PUMP/CYLINDER(S), CATALOG #9816I, SERIAL #193783 IN PLACE FROM THE INITIAL IMPLANT SURGERY. IT WAS ALSO STATED THE PHYSICIAN/SURGEON,..."THE RESERVOIR WAS BELIEVED TO HAVE A LEAK, ONCE REMOVED, NO LEAK WAS FOUND".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90207/R90215

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention