BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COSMOPLAST COLLAGEN IMPLANT (1.0ML)

    MDR report key: 1083012 · Received July 28, 2008

    Report

    Report Number
    2024601-2008-00397
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    INAMED CORP. (FREMONT)
    Product Code
    LMH
    PMA / PMN Number
    P800022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: QUALITY ASSURANCE HAS REVIEWED THE DEVICE HISTORY RECORDS FOR THIS LOT FROM FINISHED PRODUCT PACKAGING TO THE MESH BATCH. ALL STERILITY, BIOBURDEN, PYROGEN (RABBIT) AND LAL TESTING WAS PERFORMED AS REQUIRED AND ALL TESTS PASSED. DURING REVIEW OF THE DEVICE HISTORY RECORDS, MINOR DEVIATIONS WERE NOTED. NONE OF THE DEVIATIONS NOTED WERE SIGNIFICANT NOR WOULD CONTRIBUTE TO A CAUSE FOR THIS COMPLAINT. BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, WE FIND NO ASSIGNABLE CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    AFTER TREATMENT WITH COSMOPLAST 1 IN THE GLABELLAR CREASE, THE PATIENT PRESENTED WITH SWELLING AND REDNESS AT THE INJECTION SITE. THE PHYSICIAN PRESCRIBED AN ORAL ANTIBIOTIC (DICHLOXACYLIN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COSMOPLAST COLLAGEN IMPLANT (1.0ML) INJECTABLE COLLAGEN IMPLANT LMH INAMED CORP. (FREMONT) NA 07C021A

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention