BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I

    MDR report key: 730623 · Received June 29, 2006

    Report

    Report Number
    2125050-2006-00205
    Event Type
    Injury
    Date Received
    June 29, 2006
    Date of Event
    May 15, 2006
    Report Date
    June 2, 2006
    Manufacturer
    MENTOR CORPORATION - MINNESOTA DIV.
    Product Code
    FWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFORMATION THIS INFLATABLE PENILE PROSTHESIS WAS REVISED ON 05/15/2006 DUE TO AN ANEURYSM. ONE CYLINDER WAS THE SOLE COMPONENT REVEIVED FOR EVALUATION. EXAMINATION AND TESTING OF THE RETURNED COMPONENT REVEALED AN ANEURYSM IN THE CYLINDER BLADDER. TESTING REVEALED THIS TO NOT BE A SITE OF LEAKAGE. BASED ON QA'S EXAMINATION, QA CONCLUDED THAT WHILE IN-VIVO EXCESS PRESSURE MAY HAVE BEEN EXERTED ON THE CYLINDER BLADDER. QA FURTHER CONCLUDED THAT THIS PRESSURE, IN COMBINATION WITH DEVICE USAGE, COULD CONTRIBUTE TO SUFFICIENT STRESS (S) TO ANEURIZE THE BLADDER AT THIS SITE. NO SEPARATION HAD OCCURRED AT THIS AREA. AS QA WAS UNABLE TO OBTAIN THE DATE OF IMPLANT AND/OR THE SERIAL NUMBER OF THE DEVICE, QA WAS UNABLE TO DETERMINE HOW LONG THIS DEVICE HAD BEEN IMPLANTED AND ALSO UNABLE TO REVIEW THE LOT HISTORY OF THIS PRODUCT DURING THE PRODCUTION PROCESS. MANAGEMENT ROUTINELY REVIEWS MODES OF FAILURE, SUCH AS THIS. THEREFORE, NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION THERE WAS AN ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHA I INFLATABLE PENILE PROSTHESIS FWH MENTOR CORPORATION - MINNESOTA DIV. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R