BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFLATABLE PENILE PROSTHESIS

    MDR report key: 81786 · Received April 8, 1997

    Report

    Report Number
    2125050-1997-00177
    Event Type
    Injury
    Date Received
    April 8, 1997
    Date of Event
    February 26, 1997
    Report Date
    April 8, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 12/11/92. THE DEVICE WAS REMOVED ON 2/26/97, REPORTEDLY BECAUSE "NO DEFLATION [WAS] POSSIBLE" WITH THE DEVICE. ADD'L INFO INDICATED THAT THERE WERE NO APPARENT CIRCUMSTANCES IN THE PT'S HISTORY WHICH COULD HAVE CONTRIBUTED TO THIS OCCURRENCE. THE PUMP WITH AN ATTACHED CONNECTOR, TWO CYLINDERS, AND THE RESERVOIR WERE RECEIVED AND EVALUATED BY THE MFR. BEFORE STERILIZING THE DEVICE, NO SOLID, WHITE FOREIGN MATERIAL WAS DETECTED IN THE CYLINDER TUBING. HOWEVER, AFTER THE STERILIZATION PROCESS, IT WAS DETECTED BLOCKING THE TUBING OF CYLINDER #1. THEREFORE, CYLINDER #1 COULD NOT FULLY TESTED. DURING FUNCTIONAL TESTING NO ABNORMALITIES WERE DETECTED WITH THE PUMP'S VALVE MECHANISMS. BASED ON THE RECEIVED INFO AND QUALITY ASSURANCES EVALUATION, QA CONCLUDES THAT NO ABNORMALITIES WITH THIS DEVICE WOULD HAVE CONTRIBUTED TO THE DIFFICULT DEVICE DEFLATION. THE BLOCKAGE OF CYLINDER #1'S TUBING OCCURRED SUBSEQUENT TO THE DEVICE REMOVAL, AND THEREFORE IS NOT RELATED TO THE REPORTED OCCURRENCE. HOWEVER, QA IS AWARE OF OTHER CIRCUMSTANCES THAT WOULD CONTRIBUTE TO DIFFICULT DEVICE DEFLATION. THEREFORE, QA ACCPETS DIFFICULT DEVICE DEFLATION AS THE REASON FOR REMOVING THE DEVICE.

    Description of Event or Problem · 1

    PER THE INFO PROVIDED TO CO BY THE PHYSICIAN'S OFFICE THROUGH CO'S INTL REP, THE DEVICE WAS REMOVED DUE TO "DYSFUNCTION", SECONDARY TO "DEFLATION". AS REPORTED TO CO, THE ENTIRE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER CO'S 3-PIECE INFLATABLE PENILE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90063/E90072/R90067

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention