BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAQTIQUE (NON-ANIMAL STABILIZED HYLAN B GEL) INJECTION 0.75M

    MDR report key: 1063728 · Received June 20, 2008

    Report

    Report Number
    2246315-2008-00090
    Event Type
    Other
    Date Received
    June 20, 2008
    Date of Event
    November 1, 2006
    Report Date
    June 13, 2008
    Manufacturer
    GENZYME BIOSURGERY (RIDGEFIELD)
    Product Code
    LMH
    PMA / PMN Number
    P030032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    HIVE-LIKE SWELLING AT TREATMENT SITE [INJECTION SITE SWELLING]. CASE DESCRIPTION: SPONTANEOUS REPORT RECEIVED ON 13-JUN-2008 FROM A PHYSICIAN VIA A DISTRIBUTOR REGARDING A FEMALE PATIENT, (B) (6), WHO HAD A RELEVANT MEDICAL HISTORY OF: ALLERGY TO BEES, ALLERGY TO STRAWBERRIES, ALLERGY TO CIPRO. THE PATIENT RECEIVED CAPTIQUE TREATMENT IN THE LIPS IN (B) (6) 2006. SHORTLY AFTER TREATMENT, SHE EXPERIENCED EXTREME HIVE-LIKE SWELLING. SINCE HER CAPTIQUE TREATMENT, THE PATIENT HAS BEEN TREATED WITH RESTYLANE, JUVEDERM ULTRA AND JUVEDERM ULTRA PLUS, ALL ON SEPARATE OCCASIONS. WITH EACH OF THESE TREATMENTS, SHE EXPERIENCED THE SAME REACTION. SHE HAS EXPERIENCED THE SAME REACTION TO A FLU-SHOT THAT SHE RECEIVED IN (B) (6) 2007, AND ALSO ON ANOTHER OCCASION FROM AN UNKNOWN EVENT. THE PATIENT DID SEE THE TREATING PHYSICIAN AFTER HER CAPTIQUE TREATMENT, AND THE PHYSICIAN CONFIRMED THE EVENTS (HIVE-LIKE SWELLING). THE PHYSICIAN PRESCRIBED THE PATIENT CLARITIN, BENADRYL AND PREDNISONE FOR HER SYMPTOMS. AS OF THE DATE OF RECEIPT OF THIS REPORT THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT MEDICATIONS REPORTED INCLUDE: BIRTH CONTROL, ALPRAZOLAM (ALPRAZOLAM) AND ALTACE (RAMIPRIL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAQTIQUE (NON-ANIMAL STABILIZED HYLAN B GEL) INJECTION 0.75M DERMAL IMPLANT FOR AESTHETIC USE LMH GENZYME BIOSURGERY (RIDGEFIELD) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALTACE (RAMIPRIL), UNKNOWN TO UNK TO UNK| BIRTH CONTROL, UNKNOWN UNK TO UNK| ALPRAZOLAM (ALPRAZOLAM), UNKNOWN UNK TO UNK