BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 11645293 · Received April 9, 2021

    Report

    Report Number
    3013840437-2021-00085
    Event Type
    Injury
    Date Received
    April 9, 2021
    Report Date
    April 9, 2021
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, SCALES (INJECTION SITE EXFOLIATION), WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE 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.

    Description of Event or Problem · 1

    THIS MDR IS RELATED TO MDR 3013840437-2021-00084 REFERRING TO THE SAME PATIENT. THIS LITERATURE REPORT FROM (B)(6) CONCERNS A (B)(6) YEAR-OLD FEMALE PATIENT. SHE WAS INJECTED WITH 20 MG/ML OF HYALURONIC ACID, INTO THE NASOLABIAL FOLD. HYALURONIC ACID WAS INJECTED USING A 27 G NEEDLE, WITH A RETRO INJECTION TECHNIQUE WITHIN THE DEEP SUBCUTANEOUS TISSUE. THERE WAS NO SIGN OF AN INTRAVASCULAR INVOLVEMENT, IMMEDIATELY AFTER. TWO DAYS AFTER THE TREATMENT WITH HYALURONIC ACID, THE PATIENT EXPERIENCED MILD PAIN AND DUSTY BLUE RED DISCOLORATION AROUND THE PYRIFORM FOSSA. IT WAS TREATED WITH LOCAL COLD PATCHES AND NONSTEROIDAL ANTI-INFLAMMATORY DRUGS. THE PATIENT RETURNED 10 DAYS AFTER THE INJECTION SHOWING SCALES AND BLISTERS AROUND THE NASOLABIAL FOLD AND MILD ERYTHEMA AT THE SUPRA GLABELLAR AREA. IT WAS TREATED WITH 500 UNITS/ ML OF HYALURONIDASE, FOUR TIMES EVERY 45 MINUTES, WITH IMMEDIATE RELIEF OF PAIN. SHE ALSO RECEIVED AN INJECTION OF BUFLOMEDIL (REPORTED AS BUFLOMEFILO), SUBCUTANEOUSLY AND INTRADERMIC, TO RESTORE BLOOD FLOW. AS A RESULT, A DEPRESSION IN THE AREA AND GRANULAR TISSUE FOLLOWED. THE LOSS OF TISSUE REQUIRED RICH PLATELET PLASMA INFUSION AND PATCHES. DUE TO THE PROVIDED INFORMATION THE OUTCOME OF THE EVENT MILD PAIN WAS CONSIDERED AS RESOLVING (ALSO REPORTED AS RESOLVED). THE OUTCOME OF THE EVENTS DUSTY BLUE RED DISCOLORATION, SCALES, BLISTERS AND MILD ERYTHEMA WAS UNKNOWN. IN THE OPINION OF THE AUTHORS, VASCULAR COMPLICATIONS DUE TO INTRAVASCULAR INJECTION WERE UNDERREPORTED. THEREFORE, EARLY CLINICAL MANIFESTATION WAS IMPORTANT TO ACKNOWLEDGE AND RECOGNIZE, TO AVOID PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540360 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention