BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRELLE

    MDR report key: 1570746 · Received December 23, 2009

    Report

    Report Number
    MW5014161
    Event Type
    Injury
    Date Received
    December 23, 2009
    Date of Event
    November 13, 2009
    Report Date
    December 23, 2009
    Manufacturer
    COAPT SYSTEMS INC
    Product Code
    LMH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SHE HAD HYDRELLE INJECTED TO HER LIPS, NASO-LABIAL FOLDS, MARIONETTE LINES AND CHEEKS AS WELL AS A CHICKEN POX SCAR IN 2009, WITHOUT ANY COMPLICATIONS. DID GREAT FOR MANY WEEKS. THE FOLLOWING MONTH, SHE DEVELOPED SEVERE GENERAL FACIAL EDEMA. SHE WAS ADMITTED TO THE HOSP EMERGENCY DEPARTMENT. I SAW HER THERE. WAS HAVING A DIFFUSE ALLERGIC REACTION SUPPORTED BY HISTORY, EXAM AND LABS -HIGH EOSINOPHIL COUNT-. SHE WAS PLACED ON ORAL STEROIDS, ORAL ANTIBIOTICS AND ORAL BENADRYL. SHE WAS SEEN MULTIPLE TIMES SINCE THEN. SHE WAS SEEN BY HER PRIMARY CARE DOCTOR AS WELL WHO INCREASED HER ORAL STEROID DOSE AND TAPER. A FEW DAYS LATER, THE SWELLING RESOLVED BUT THEN SHE STARTED DEVELOPING VERY LARGE MASSES ALL OVER HER FACE IN THE INJECTION AREAS. SHE REQUIRED MANY SESSIONS OF INJECTIONS WITH HYALURONIDASE, AND KENALOG TO RESOLVE THIS IN ADDITION TO ORAL ANTIBIOTICS. SHE EVEN HAD 3 LARGE ABSCESS FILLED POCKETS THAT REQUIRED DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRELLE HYDRELLE LMH COAPT SYSTEMS INC V08D107BA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| S