BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IPP INFLATABLE PENILE PROSTHESIS

    MDR report key: 82101 · Received April 9, 1997

    Report

    Report Number
    2125050-1997-00184
    Event Type
    Injury
    Date Received
    April 9, 1997
    Date of Event
    December 5, 1996
    Report Date
    April 9, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS IMPLANTED ON 4/11/94 AND REVISED ON 12/6/96 DUE TO "INSUFFICIENT RIGIDITY." A PUMP AND TWO CYLINDERS WERE RETURNED FOR EVALUATION. 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 ON THE RETURNED COMPONENTS REVEALED NO FUNCTIONAL ABNORMALITIES. BASED ON THIS QA CONCLUDED THAT NO FUNCTIONAL ABNORMALITIES CONTRIBUTED TO THE REPORTED EVENT. BECAUSE THE LIMITED INFO RECEIVED DOES NOT INDICATE WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS OCCURRENCE, QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE "INSUFFICIENT RIGIDITY."

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED DUE TO "INSUFFICIENT RIGIDITY". AS REPORTED TO CO, THE PUMP, CYLINDER(S) AND SOME ASSEMBLY KIT COMPONENT(S) ONLY WERE REMOVED AND REPLACED; LEAVING THE RESERVOIR COMPONENT. CATALOG #9075K. SERIAL #162171 INPLACE FROM THE INITIAL IMPLANT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IPP INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90105/E90099/R90103

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention