BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYPLAST COLLAGEN IMPLANT (1.0ML)

    MDR report key: 949597 · Received November 16, 2007

    Report

    Report Number
    2024601-2007-00571
    Event Type
    Malfunction
    Date Received
    November 16, 2007
    Date of Event
    October 15, 2007
    Report Date
    October 18, 2007
    Manufacturer
    INAMED CORP. (FREMONT)
    Product Code
    LMH
    PMA / PMN Number
    P800022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDWATCH SENT TO FDA ON 11/16/2007. ALLERGAN RECEIVED AN INCOMPLETE LOT NUMBER FOR THIS EVENT. WE ARE UNABLE TO PROVIDE FURTHER INFORMATION AT THIS TIME. WHEN OR IF WE DO WE WILL FORWARD THE INFORMATION APPROPRIATELY.

    Description of Event or Problem · 1

    DURING TREATMENT WITH ZYPLAST A TOTAL NEEDLE DISENGAGEMENT OCCURRED 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 ZYPLAST COLLAGEN IMPLANT (1.0ML) INJECTABLE COLLAGEN IMPLANT LMH INAMED CORP. (FREMONT) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR