BEUDAMED
    FDA Adverse Event Other Summary report: N

    COSMOPLAST COLLAGEN IMPLANT (1.0ML)

    MDR report key: 1202756 · Received October 10, 2008

    Report

    Report Number
    2024601-2008-00784
    Event Type
    Other
    Date Received
    October 10, 2008
    Date of Event
    May 29, 2008
    Report Date
    August 1, 2008
    Manufacturer
    INAMED CORP. (FREMONT)
    Product Code
    LMH
    PMA / PMN Number
    P800022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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, NO DEVIATIONS WERE NOTED. BASED ON THE REVIEW OF THE DEVICE HISTORY RECORDS, WE FIND NO ASSIGNABLE CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    A PT WAS TREATED WITH COSMOPLAST IN THE FINE LINES AND LIPS AND JUVEDERM ULTRA PLUS IN THE NASOLABIAL FOLDS AND MARIONETTE LINES ABOUT ONE MONTH PRIOR. ABOUT TWO WEEKS AFTER TREATMENT WITH COSMOPLAST, THE PT PRESENTED WITH MILD RED STREAKS AND A RED CRESCENT AT THE BOTTOM OF THE NASOLABIAL FOLDS WHERE BOTH PRODUCTS WERE PLACED. NO TREATMENT HAS BEEN GIVEN. THE PT FEELS THE WRINKLE LOOKS WORST WHERE THE COSMOPLAST WAS TREATED. FOLLOW-UP WITH THE PHYSICIAN NOTED THAT AFTER THE JUVEDERM ULTRA PLUS TREATMENT, THE PT HAD PRESENTED WITH A LUMP ON THE LEFT SIDE OF THE LIPS. TWO MONTHS AFTER THE COSMOPLAST TREATMENT, THE PT PRESENTED WITH INDENTS IN THE MARIONETTE LINES. AFTER FURTHER FOLLOW-UP WITH THE PHYSICIAN, IT WAS STATED THAT THIS IS AN "UNUSUAL EVENT" AND WAS NOT DUE TO PRODUCT MIGRATION OR LUMPING OF PRODUCT. THE PHYSICIAN ALSO NOTED THE INDENTS ARE LITERALLY INDENTED INTO THE PATIENT'S FACE. THIS IS THE SAME EVENT AND THE SAME PT REPORTED UNDER MDR ID# 3005113652-2008-00063. THIS SECOND MDR IS BEING SUBMITTED FOR THE SECOND SUSPECT PRODUCT.

    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 07D062A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Disability VITAMIN E| ADVIL