BEUDAMED
    FDA Adverse Event Other Summary report: N

    BELOTERO BASIC (INJECTION)

    MDR report key: 2860256 · Received November 26, 2012

    Report

    Report Number
    2135225-2012-00149
    Event Type
    Other
    Date Received
    November 26, 2012
    Date of Event
    October 21, 2012
    Report Date
    October 22, 2012
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN CONSIDERED THE EVENTS AS CAUSED BY AN INFECTION AND NOT RELATED TO BELOTERO AND UNDER APPROPRIATE TREATMENT THE EVENTS WERE RESOLVING. MERZ AGREES WITH THE REPORTER AND CAUSALITY IS ASSESSED AS NOT RELATED FOR ALL EVENTS. THE DEVICE HISTORY RECORDS WERE NOT REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS FORWARDED TO MERZ AESTHETICS BY MERZ PHARMACEUTICALS (B)(4), INITIALLY RECEIVED FROM A (B)(6) PHYSICIAN. A FEMALE PT WAS INJECTED WITH 0.2 ML OF BELOTERO BASIC DERMAL FILLER WITH THREE INJECTION POINTS INTO GLABELLA. THE NEEDLE USED FOR INJECTION WAS A 27G CANNULA. ON (B)(6) 2012, THE PT EXPERIENCED LOCALIZED SCALING ERYTHEMA AND ITCHING. REPORTEDLY, LOCALIZED SCALING ERYTHEMA FIRST APPEARED AS A LIVID DISCOLORATION, CHANGING TO A PALE ERYTHEMA AFTER ONE WEEK. INITIALLY, THE PHYSICIAN REPORTED THE EVENTS LOCALIZED LIVID DISCOLORATION AND FORMATION OF NODULES IN THE GLABELLAR AREA. CORRECTIVE TREATMENT COMPRISED PRESCRIPTION OF AN UNSPECIFIED LOCAL CORTICOID. ON (B)(6) 2012, THE PT WAS PLACED ON ORAL CEFACLOR 1000 MG/D FOR 7 DAYS. THE PHYSICIAN ASSUMED THAT THE SYMPTOMS PROBABLY RESULTED FROM A SOFT TISSUE INFECTION AND EXCLUDED A NECROSIS. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENTS WAS CONSIDERED RESOLVING. IN THE OPINION OF THE REPORTING PHYSICIAN, THE EVENTS WERE OF MODERATE INTENSITY AND NOT RELATED TO THE INJECTION OF BELOTERO BASIC. SHE CONSIDERED THE EVENTS NOT LEADING TO PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BELOTERO BASIC (INJECTION) NONE LMH ANTEIS S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other