BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZYDERM 1 COLLAGEN IMPLANT (1.0ML)

    MDR report key: 1081565 · Received July 25, 2008

    Report

    Report Number
    2024601-2008-00392
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 27, 2008
    Manufacturer
    INAMED CORP (FREMONT)
    Product Code
    LMH
    PMA / PMN Number
    P800022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY SUMMARY: WE HAVE REVIEWED THE DEVICE HISTORY RECORDS FOR THE SYRINGES AND NEEDLES USED AND ALL DIMENSIONAL REQUIREMENTS WERE MET. DURING REVIEW OF THE DEVICE HISTORY RECORDS, NO DEVIATIONS WERE NOTED. BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, WE FIND NO ASSIGNABLE CAUSE FOR THIS COMPLAINT. IF YOU HAVE ANY QUESTIONS, PLEASE FEEL FREE TO CONTACT US.

    Description of Event or Problem · 1

    DURING TREATMENT WITH ZYDERM 1, THE NEEDLE DISENGAGED AND PRODUCT WAS LOST. THERE WAS NO INJURY TO THE PT OR TO THE INJECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZYDERM 1 COLLAGEN IMPLANT (1.0ML) INJECTABLE COLLAGEN IMPLANT LMH INAMED CORP (FREMONT) NA 07J012 C

    Patients

    Seq Age Sex Outcome Treatment
    1