BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COAPTITE

    MDR report key: 1060385 · Received June 12, 2008

    Report

    Report Number
    2135225-2008-00035
    Event Type
    Injury
    Date Received
    June 12, 2008
    Report Date
    June 10, 2008
    Manufacturer
    BIOFORM MEDICAL, INC.
    Product Code
    LNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ADVERSE EVENT WAS NOT REPORTED BY ANY OF THE AUTHORS (LAI, HURTADO OR APPELL) TO COAPTITE DIST, BOSTON SCIENTIFIC CORP OR THE COAPTITE MFR, BIOFORM MEDICAL, INC. THE PHYSICIAN WHO PERFORMED THE ACTUAL COAPTITE PROCEDURE AND F/U TREATMENT WAS NOT IDENTIFIED IN THE ARTICLE. THE PROCEDURE DATE IS UNK. THE DEVICE LOT # HAS NOT BEEN IDENTIFIED; THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    AN ARTICLE ACCEPTED FOR SUBMISSION IN THE "INTERNATIONAL UROGYNECOLOGY JOURNAL 2008" DESCRIBES THE FOLLOWING COAPTITE RELATED PT EVENT. A PT WAS INJECTED WITH 2 CC COAPTITE FOR SUI AND ISD CORRECTION. SEVEN MOS LATER, THE PT RETURNED FOR EVAL DUE TO PROGRESSIVE DIFFICULTY IN VOIDING. THE URETHRAL LUMEN WAS COMPRESSED BY PROLAPSED MUCOSA. THIS TISSUE WAS INCISED AND CAHA WAS REMOVED. THE PROLAPSE HAS HEALED AT A ONE MO F/U AND THE PT REC'D THREE ADD'L INJECTIONS OF COAPTITE WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COAPTITE INJECTABLE IMPLANT LNM BIOFORM MEDICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention