BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSMODERM 1 COLLAGEN IMPLANT (1.0ML)

    MDR report key: 1200076 · Received October 15, 2008

    Report

    Report Number
    2024601-2008-00794
    Event Type
    Malfunction
    Date Received
    October 15, 2008
    Date of Event
    September 15, 2008
    Report Date
    September 17, 2008
    Manufacturer
    INAMED CORP. (FREMONT)
    Product Code
    LMH
    PMA / PMN Number
    P800022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING TREATMENT WITH COSMODERM, THE NEEDLE DISENGAGED AND PRODUCT WAS LOST. THERE WAS NO INJURY TO THE PATIENT OR TO THE INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSMODERM 1 COLLAGEN IMPLANT (1.0ML) INJECTABLE COLLAGEN IMPLANT LMH INAMED CORP. (FREMONT) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR