BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAPTIQUE (NON-ANIMAL STABILIZED HYLAN B GEL) INJECTION

    MDR report key: 1378328 · Received April 30, 2009

    Report

    Report Number
    2246315-2009-00068
    Event Type
    Other
    Date Received
    April 30, 2009
    Date of Event
    March 1, 2009
    Report Date
    April 22, 2009
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    LMH
    PMA / PMN Number
    P030032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# R0620, EXPIRY DATE 02/2008 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED.

    Description of Event or Problem · 1

    SWELLING OF ENTIRE FACE [SWELLING FACE], ALLERGIC REACTION [HYPERSENSITIVITY], LOSS OF FEELING IN LIPS [SENSORY LOSS], LUMPS ON SIDES OF LIPS [INJECTION SITE NODULE]. CASE DESCRIPTION: A SPONTANEOUS REPORT WAS RECEIVED ON (B)(6) 2009, FROM A HEALTHCARE PROVIDER (HCP) VIA DISTRIBUTOR REGARDING A FEMALE PATIENT OF UNKNOWN AGE WHO EXPERIENCED SWELLING OF THE ENTIRE FACE, ALLERGIC REACTION, LOSS OF FEELING IN THE LIPS AND LUMPS ON THE SIDES OF THE LIPS AFTER TREATMENT WITH CAPTIQUE. THE PATIENT HAD NO HISTORY OF PREVIOUS TREATMENT WITH DERMAL FILLERS. SHE RECEIVED INJECTIONS OF CAPTIQUE IN THE LIPS AND LIP BORDER ON AN UNSPECIFIED DATE IN (B)(6) 2009. ON AN UNSPECIFIED DATE, SHE PRESENTED WITH SWELLING OF THE ENTIRE FACE. SHE WAS TREATED WITH A STEROID INJECTION AND MEDROL DOSEPAK "TO DECREASE THE ALLERGIC REACTION". IT WAS NOTED THAT THE PATIENT HAD NO KNOWN ALLERGIES, NO HISTORY OF AUTOIMMUNE DISEASE AND WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE HCP STATED THAT A FRIEND RECEIVED TREATMENT FROM THE SAME SYRINGE WITH A DIFFERENT NEEDLE AND HAD NO REACTION. APPROXIMATELY A MONTH AFTER TREATMENT WITH CAPTIQUE, THE PATIENT REPORTED THAT "SOME OF THE FEELING BACK IN HER LIPS" AND LUMPS WERE PRESENT ON THE SIDES OF HER LIPS. THE PRODUCTION AND QUALITY CONTROL DOCUMENTATION FOR LOT# R0620, EXPIRY DATE 02/2008 WERE REVIEWED. THE INVESTIGATION SHOWED THAT THE PRODUCT MET SPECIFICATIONS. NO ASSOCIATED NON-CONFORMANCES WERE NOTED. AT THE TIME OF THIS REPORT, THE OUTCOME OF THE PATIENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPTIQUE (NON-ANIMAL STABILIZED HYLAN B GEL) INJECTION DERMAL IMPLANT FOR AESTHETIC USE LMH GENZYME BIOSURGERY (RIDGEFIELD) UNK R06201

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention