BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE

    MDR report key: 9141761 · Received October 1, 2019

    Report

    Report Number
    3013840437-2019-00008
    Event Type
    Injury
    Date Received
    October 1, 2019
    Report Date
    October 1, 2019
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, CETUXIMAB RELATED DERMAL FILLER REACTION (DRUG-DEVICE INTERACTION), WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATING 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. ARTICLE CITATION: PATHMANATHAN S., DZIENIS M. BMJ CASE REP 2019; 12: E228882. DOI: 10.1136/BCR-2018-228882 - [(B)(4)].

    Description of Event or Problem · 1

    THIS LITERATURE REPORT FROM (B)(6), CONCERNS A (B)(6)-YEAR-OLD MALE PATIENT. HE WAS INJECTED WITH HYALURONIC ACID INTO BOTH CHEEKS, 6 MONTHS PRIOR TO THE EVENTS. AFTERWARDS, THE PATIENT WAS DIAGNOSED WITH GLOSSOTONSILLARY MALIGNANCY (ALSO REPORTED AS, 3.1 CM P16-POSITIVE BASE-OF-TONGUE PRIMARY WITH FOUR LEFT SIDED LYMPH NODES INVOLVED, STAGED AS CT2N2BM0). CONSEQUENTLY, HE WAS TREATED WITH CONCURRENT RADIATION (70 GY/35 FRACTIONS) AND CETUXIMAB. TWO HOURS AFTER THE FIRST DOSE OF CETUXIMAB WAS GIVEN, THE PATIENT DEVELOPED AN ACUTE DERMAL FILLER INFLAMMATION MANIFESTING IN A FORM OF NODULES AND OEDEMA, AROUND THE DERMAL FILLER SITES. THE SYMPTOMS GRADUALLY PROGRESSED OVER THE NEXT 48 HOURS. THE DERMAL FILER SITES WERE REVIEWED BY A COSMETIC SPECIALIST AND A PROVISIONAL DIAGNOSIS OF CETUXIMAB-RELATED DERMAL FILLER REACTION WAS MADE. AFTER A DISCUSSION WITH THE ONCOLOGY TEAM, HYALURONIDASE WAS INJECTED TO DISSOLVE THE DERMAL FILLERS. MULTIPLE INJECTIONS (5000 IU IN 5 ML) OVER 2 DAYS WERE INJECTED. WITHIN 24 HOURS THE NODULES AND OEDEMA STARTED TO SETTLE. THE PATIENT CONTINUED WITH CETUXIMAB WITHOUT RECURRENCE OF THE DERMAL REACTION AROUND THE FILLER SITES. HOWEVER, HE DEVELOPED A TYPICAL CETUXIMAB-RELATED ACNEIFORM RASH AROUND NOSE AND FOREHEAD AND LATER REQUIRED A DOSE REDUCTION AND ULTIMATELY FINAL DOSE OMISSION DUE TO EXCESSIVE ORAL MUCOSITIS AND RADIOTHERAPY-INDUCED IN-FIELD DERMATITIS. THE OUTCOME OF THE EVENT WAS REPORTED AS RESOLVED. IN THE OPINION OF THE AUTHOR, A COMBINATION OF THE UPREGULATION OF INFLAMMATION SECONDARY TO THE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) INHIBITION IN THE EPIDERMIS AND THE DERMAL FILLERS BEING MORE PRONE TO BOTH CHRONIC INFLAMMATION OR A HYPERSENSITIVITY REACTION MAY HAVE LED TO THE ACUTE DERMAL FILLER INFLAMMATION OBSERVED IN THE PATIENT. CETUXIMAB CAN LEAD TO INFLAMMATION AROUND THE DERMAL FILLER SITES, WHICH CAN BE TREATED WITH DISSOLUTION OF THE FILLER. THIS OBSERVATION WAS IMPORTANT SINCE THE TREATMENT WITH CETUXIMAB CAN BE SAFELY CONTINUED AFTER DISSOLUTION OF THE FILLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934852 BELOTERO BALANCE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention