BEUDAMED
    FDA Adverse Event Summary report: N

    CAPTIQUE

    MDR report key: 641930 · Received October 18, 2005

    Report

    Report Number
    2246315-2005-00109
    Date Received
    October 18, 2005
    Date of Event
    September 19, 2005
    Report Date
    September 23, 2005
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED FROM A DR IN 2005 REGARDING A PT WITH MEDICAL HISTORY SIGNIFICANT FOR AN ALLERGY TO LATEX. THE PT RECEIVED INJECTIONS OF CAPTIQUE ON AUGUST 24, 2005 TO THE NASOLABIAL FOLDS. THE FOLLOWING MONTH, THE PT EXPERIENCED TENDERNESS, PAIN, AND SOME HARDNESS IN THE LOWER CHEEK AREAS. THREE DAYS LATER THE PT WAS SEEN IN THE TREATING DR'S OFFICE. THE DR PRESCRIBED A 7 DAY COURSE ON CLINDAMYCIN AND A MEDROL DOSE PAK. ON AN UNK DATE THE PT'S PRIMARY CARE DR HAD PRESCRIBED ETODOLAC (LODINE) FOR PAIN. AT THE TIME OF THE REPORT, THE PT HAD NOT YET RECOVERED. ADDITIONAL INFO RECEIVED 5 DAYS LATER FROM A NURSE IN THE TREATING DR'S OFICE, WHO STATED THE PT WAS SEEN IN THE OFFICE, AND HAD NOT TAKEN THE MEDROL DOSE PAK. ADDITIONAL INFO RECEIVED FROM THE TREATING DR, WHO REPORTED THE PT'S CONDITION HAD WORSENED AND IT LOOKED IKE INDENTICAL SYMMETRICAL CYSTS LOCATED IN THE LOWER LAST 1/4 OF THE NASOLABIAL FOLDS. THE DR STATED HE DID NOT FEEL IT WAS AN ALLERGIC REACTION. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTIQUE DERMAL IMPANT FOR AESTHETIC USE LMH GENZYME BIOSURGERY NA P0515

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention