BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 47613 · Received November 8, 1996

    Report

    Report Number
    2125050-1996-00495
    Event Type
    Injury
    Date Received
    November 8, 1996
    Date of Event
    March 1, 1993
    Report Date
    November 8, 1996
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE RECEIVED INFO, THIS PENILE PROSTHESIS WAS IMPLANTED ON 2/19/1993. ON 9/5/1996 A RECEIVED COMPLAINT FROM A PT REP STATED, "[THE PT] EXPERIENCED AN INFECTION AND THE IMPLANT WAS REMOVED IN 3/1993." THE PT REP HAS NOT PROVIDED A MEANS OR RELEASE TO CONTINUE WITH THIS INVESTIGATION. TO DATE, THIS COMPLAINT HAS NOT BEEN REPORTED BY A MEDICAL PROFESSIONAL OR CONFIRMED BY THE MFR. WITHOUT INFO FROM A MEDICAL PROFESSIONAL OR AN EXPLANTED DEVICE, QUALITY ASSURANCE IS PRECLUDED FROM COMMENTING ON THIS OCCURRENCE. SHOULD ADDITIONAL INFO AND/OR THE EXPLANTED DEVICE BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND RE-EVALUATED, ACCORDING TO PROCEDURES.

    Description of Event or Problem · 1

    PER THE INFO PROVIDED TO CO BY MEANS OF THE PT'S REP, THE DEVICE WAS REMOVED DUE TO AN "INFECTION".

    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 E90066, E90060, R90061

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention