BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPH I INFLATABLE PENILE PROSTHESIS

    MDR report key: 111016 · Received August 7, 1997

    Report

    Report Number
    2125050-1997-00439
    Event Type
    Injury
    Date Received
    August 7, 1997
    Date of Event
    July 1, 1997
    Report Date
    July 15, 1997
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE AVAILABLE INFO THIS INFLATABLE PENILE PROSTHESIS WAS REVISED ON 7/1/97 BECAUSE THE DEVICE WAS "NON-FUNCTIONING." NO IMPLANT INFO WAS PROVIDED. A PUMP AND TWO CYLINDERS WERE RETURNED FOR EVAL. REQUESTS HAVE BEEN MADE FOR ADD'L INFO SURROUNDING THE INCIDENT, HOWEVER, TO DATE THE REQUESTED INFO HAS NOT BEEN REC'D. WITHOUT THE REQUESTED INFO, QA IS PRECLUDED FROM COMMENTING ON THE EVENTS SURROUNDING THE INCIDENT. SHOULD ADD'L INFO BE REC'D, QA WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE WITH PROCEDURES. EXAMINATION AND TESTING OF THE RETURNED COMPONENTS REVEALED NO FUNCTIONAL ABNORMALITIES. BASED ON THIS QA CONCLUDED THAT NO FUNCTIONAL ABNORMALITIES CONTRIBUTED TO THE REPORTED "NON-FUNCTIONING." BECAUSE THE REC'D INFO DID NOT INDICATE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE "NON-FUNCTIONING" OF THE DEVICE, AND BECAUSE NO FUNCTIONAL ABNORMALITIES WERE DETECTED, QA IS PRECLUDED FROM DETERMINING THE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    PER THE INFORMATION PROVIDE TO CO BY THE PHYSICIAN'S OFFICE, THE DEVICE WAS REMOVED AS IT WAS "NON-FUNCTIONING." AS REPORTED TO CO, THE ENTIRE DEVICE, WITH THE EXCEPTION OF THE RESERVOIR, WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPH I INFLATABLE PENILE PROSTHESIS Implant INFLATABLE PENILE PROSTHESIS FHW MENTOR UROLOGY, INC. NA E90194

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention