BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARK II INFLATABLE PENILE PROSTHESIS

    MDR report key: 38022 · Received September 13, 1996

    Report

    Report Number
    2125050-1996-00441
    Event Type
    Injury
    Date Received
    September 13, 1996
    Date of Event
    July 17, 1996
    Report Date
    September 13, 1996
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO THIS DEVICE WAS IMPLANTED ON 4/26/90 AND REMOVED ON 7/17/96 BECAUSE IT WAS "DEFECTIVE." REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT; HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE DEVICE REVEALED NO FUNCTIONAL ABNORMALITIES. BASED ON THIS QA CONCLUDED THAT NO FUNCTIONAL ABNORMALITIES CONTRIBUTED TO THIS EVENT. BECAUSE THE LIMITED INFO DOES NOT PROVIDED ANY INDICATION WHAT FACTOR(S) MAY HAVE CONTRIBUTED TO THE DEVICE BEING "DEFECTIVE," AND BECAUSE NO FUNCTIONAL ABNORMALITIES WERE DETECTED, QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED AS IT WAS "DEFECTIVE". THE ENTIRE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MARK II INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA 012513

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention