BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 8845877 · Received July 31, 2019

    Report

    Report Number
    2135225-2019-00069
    Event Type
    Injury
    Date Received
    July 31, 2019
    Report Date
    September 3, 2019
    Manufacturer
    ANTEIS S. A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW-UP INFORMATION WAS RECEIVED ON 30-JUL-2019:THE AUTHOR REPORTED THAT SHE WAS NOT INFORMED WHICH PRODUCT WAS USED, BUT NOTED THAT THE PATIENT MADE A NOTE OF THE ACTIVE SUBSTANCE AND SAID THAT HYALURONIC ACID WAS INJECTED. AS REPORTED, THE PATIENT WAS INJECTED WITH HYALURONIC ACID ABROAD. THE COUNTRY IN WHICH THE PATIENT WAS INJECTED WAS UNKNOWN (PREVIOUSLY REPORTED AS TURKEY).

    Description of Event or Problem · 0

    FOLLOW-UP INFORMATION WAS RECEIVED ON 30-JUL-2019:THE AUTHOR REPORTED THAT SHE WAS NOT INFORMED WHICH PRODUCT WAS USED, BUT NOTED THAT THE PATIENT MADE A NOTE OF THE ACTIVE SUBSTANCE AND SAID THAT HYALURONIC ACID WAS INJECTED. AS REPORTED, THE PATIENT WAS INJECTED WITH HYALURONIC ACID IN TURKEY.

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, PSEUDOCYSTIC ENCAPSULATION, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF RESULTS IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT REPORTED. LANGER C, WITTEKINDT C. ADVERSE EVENT OF HYALURONIC ACID FILLER INJECTIONS - TWO CASE REPORTS. LARYNGO-RHINO-OTOLOGIE 2018; 97(S02): 306 - 306. DOI:10.1055/S-0038-1640794.

    Description of Event or Problem · 1

    THIS CASE IS LINKED TO 2135225-2019-00068. THIS LITERATURE REPORT FROM (B)(6) CONCERNS A FEMALE PATIENT. SHE WAS INJECTED INTRADERMALLY WITH HYALURONIC ACID INTO THE CHEEK REGION, SOME YEARS PRIOR TO PRESENTATION. ON AN UNKNOWN DATE AFTER THE TREATMENT WITH HYALURONIC ACID, THE PATIENT DEVELOPED PSEUDOCYSTIC ENCAPSULATION. THE PATIENT SHOWED A BILATERAL NODULE IN THE HYALURONIC ACID TREATED REGION WITHOUT INFLAMMATORY SIGNS, WHICH WAS FIRST ASSUMED TO BE A SIALADENOSIS. SONOGRAPHY AND MRI EXAMINATION SHOWED LIQUID SUBDERMAL AREAS WITHOUT CONTACT TO THE SALIVARY GLANDS. DIAGNOSTIC PUNCTURE OF THE CYSTS WAS PERFORMED, AND A FEW MILLILITERS OF OPAQUE SECRETION WAS SENT TO CYTOLOGICAL EXAMINATION WHICH SHOWED GRANULOCYTES, PROTEIN PARTS AND FOREIGN-BODY GIANT CELLS. THE CYSTIC LESIONS WERE INTERPRETED AS PSEUDOCYSTIC ENCAPSULATION AS LATE ADVERSE EVENT OF THE HYALURONIC ACID INJECTION. MULTIPLE PUNCTURES OF THE LIQUID WERE PERFORMED AND REDUCED THE CYSTS TO A TOLERABLE MINIMUM. THE OUTCOME OF THE EVENT WAS REPORTED AS RESOLVING. IN THE OPINION OF THE AUTHOR, PSEUDOCYSTIC ENCAPSULATIONS AS LATE ADVERSE EVENT OF AN AESTHETIC TREATMENT WITH INJECTED HYALURONIC ACID COULD BE A DIAGNOSTIC AND THERAPEUTIC CHALLENGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638809 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S. A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R| S CONCOMITANT DRUG NOT AVAILABLE.| CONCOMITANT DRUG NOT AVAILABLE