BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHA I INFLATABLE PENILE PROSTHESIS

    MDR report key: 44720 · Received October 28, 1996

    Report

    Report Number
    2125050-1996-00531
    Event Type
    Injury
    Date Received
    October 28, 1996
    Date of Event
    September 16, 1996
    Report Date
    October 24, 1996
    Manufacturer
    MENTOR UROLOGY, INC.
    Product Code
    FHW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO CONCERNING THIS EVENT, AND RETURN OF THE EXPLANTED PROSTHESIS WAS REQUESTED. HOWEVER, AT THIS TIME NO RESPONSE HAS BEEN RECEIVED. IN ADDITION, NO RECORD OF IMPLANT HISTORY FOR THIS DEVICE HAS BEEN OBTAINED AT THIS TIME AND QA IS UNABLE TO VERIFY THE DEVICE REFERENCED WAS MANUFACTURED BY THIS CORPORATION. IN ADDITION, WITHOUT THE BENEFIT OF EXAMINATION AND TESTING OF THE DEVICE QA IS PRECLUDED FROM CONFIRMING THIS REPORT OR DETERMINING THE CAUSE. SHOULD ADD'L INFO AND OR THE DEVICE BE RECEIVED, QA WILL FILE AND ADDENDUM TO THIS REPORT.

    Description of Event or Problem · 1

    THE DEVICE WAS REMOVED DUE TO "BROKEN TUBING". AS REPORTED TO THE MFR, THE CYLINDER AND PUMP COMPONENT ONLY WERE REMOVED AND REPLACED; LEAVING THE INITIAL IMPLANTED RESERVOIR COMPONENT IN PLACE. 10/24/96-UPON RECEIPT OF INFO PROVIDED TO CO BY THE PHYSICIAN/SURGEON'S OFFICE IT WAS STATED... "PARTIAL TEARS, ONE IN EACH CYLINDER TUBE". ADDITIONALLY , THE PHYSICIAN REPORTED... "PT FREQUENTLY PUMPED UP THE CYLINDERS AS MUCH AS HE POSSIBLY COULD".

    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 47 YR Required Intervention