BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRELLE

    MDR report key: 1894077 · Received November 2, 2010

    Report

    Report Number
    MW5018071
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    August 20, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ANIKA, DISTRIBUTED BY COAPT
    Product Code
    LMH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A BAD REACTION TO HYDRELLE -INJECTABLE FILLER- (B)(6) 2010, I HAD INJECTIONS IN SEVERAL AREAS. SEVEN WEEKS AFTER THE INJECTIONS OF HYDRELLE HUGE SWELLINGS BLEW UP OVER 2 DAYS ON CHEEKS, JAW, LIP, FOREHEAD, UNDER EYES. AFTER BIOPSIES, CAT SCAN, HOSPITALIZATION WITH IV ANTIBIOTICS, 15 ABSCESSES DRAINED OF LARGE POCKETS OF PUS, ETC. I FOUND A DOCTOR WHO FOUND ANSWERS. SHE DISCOVERED MANY DOCTORS WERE EXPERIENCING PTS WITH STERILE ABSCESSES AND SWELLING IN RESPONSE TO THE HYDRELL. MY DOCTOR WARNED ME THAT I WOULD PROBABLY HAVE RE-OCCURRENCES UNTIL THE PRODUCT FINALLY IS ABSORBED. ONE TO TWO YEARS. MY DOCTOR FEELS THAT THIS FILLER SHOULD BE TAKEN OFF THE MARKET. FURTHER, BECAUSE THE PRODUCT WAS KNOWN TO BE PROBLEMATIC WHEN THE ORIGINAL COMPANY SOLD IT... THE NEW COMPANY KNEW THAT BUT CHANGED THE NAME AND SOLD IT ANYWAY - ACCORDING TO MY DOCTOR. SHE SAID MANY OF THE DOCTORS WOULDN'T HAVE AGREED TO USE IT HAD THEY KNOW, IT WAS THE SAME INFERIOR PRODUCT WITH A NEW NAME. I HOPE THIS INFO HELPS. DOSE OR AMOUNT: VIAL, FREQUENCY: 1 TIME, ROUTE: ID. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: THINNING. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRELLE HYDRELLE, FORMERLY ELEVESS LMH ANIKA, DISTRIBUTED BY COAPT

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| S HYDRELLE