BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 77956 · Received March 25, 1997

    Report

    Report Number
    2125050-1997-00141
    Event Type
    Injury
    Date Received
    March 25, 1997
    Date of Event
    February 14, 1997
    Report Date
    March 25, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS REVISED ON 2/14/97 TO REPOSITION THE RESERVOIR. A CONNECTOR ONLY WAS REPLACED. ACCORDING TO THE HOSPITAL THIS CONNECTOR WAS DESTROYED. NO IMPLANT INFO WAS PROVIDED. REQUESTS FOR ADD'L INFO SURROUNDING THIS EVENT HAVE BEEN MADE, HOWEVER, TO DATE THE INFO HAS NOT BEEN RECEIVED. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THIS INCIDENT. SHOULD ADD'L INFO BE RECEIVED, QA WILL RE-EVALUATE THIS EVENT IN ACCORDANCE WITH PROCEDURES. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANTED CONNECTOR. QA IS PRECLUDED FROM CONFIRMING ANY OBSERVATIONS AND PRECLUDED FROM COMMENTING ON ITS CONDITION. HOWEVER, BECAUSE QA'S EXAMINATION COULD NEITHER CONFIRM NOR DISPROVE THE NEED TO REPOSITION THE RESERVOIR, AND BECAUSE A CONNECTOR ONLY WAS REPLACED AND THE REMAINING COMPONENTS REMAIN IMPLANTED AND ARE FUNCTIONING AS INTENDED, QA ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION.

    Description of Event or Problem · 1

    THE DEVICE RESERVOIR COMPONENT "WAS REPOSITIONED ONLY". AS REPORTED TO CO, THE SURGICAL REVISION EMPLOYED CONNECTOR FROM AN ASSEMBLY KIT. THE CONNECTOR WHICH WAS REMOVED HAS BEEN DESTROYED BY THE HOSP'S PROSTHESIS ROOM.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention