BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE LIDOCAINE

    MDR report key: 17279279 · Received July 7, 2023

    Report

    Report Number
    3013840437-2023-00074
    Event Type
    Injury
    Date Received
    July 7, 2023
    Report Date
    July 7, 2023
    Manufacturer
    ANTEIS S.A
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA, AS THE EVENT ANGIOEDEMA (PT: ANGIOEDEMA), WAS DEEMED TO MEET THE SERIOUS CRITERIA OF HOSPITALIZATION. THE DEVICE HISTORY RECORD OF BELOTERO BALANCE LIDOCAINE, LOT NUMBER 326125/1, WAS REVIEWED. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO OTHER SIMILAR EVENTS WERE NOTED. NO NONCONFORMANCES WERE NOTED RELATED TO THIS LOT.

    Description of Event or Problem · 0

    THIS CASE WAS LINKED TO LSSMV CASE NUMBERS (B)(4), REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A MALAYSIAN PHYSICIAN AND CONCERNS A 58-YEAR-OLD MALE PATIENT. HE WAS INJECTED WITH A TOTAL OF 1 ML BELOTERO BALANCE LIDOCAINE INTO THE UNDEREYE (OFF LABEL USE OF DEVICE), ON (B)(6) 2022. BATCH NUMBER WAS REPORTED AS 326125/1 (EXPIRY DATE: 10/2023). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. HE WAS INJECTED WITH 0.5 ML PER SIDE. THE PATIENT WAS CONCOMITANTLY INJECTED WITH A TOTAL OF 2 ML OF BELOTERO VOLUME LIDOCAINE, INTO THE UNDEREYE, ON (B)(6) 2022. BATCH NUMBER WAS REPORTED AS 557196/1 (EXPIRY DATE: 06/2023). HE WAS INJECTED WITH 1 ML PER SIDE. A SANDWICH TECHNIQUE WAS USED. THE PATIENT WAS CONCERNED ABOUT LOOKING TIRED WAS HEALTHY AND WITH NO ALLERGIES. ON THE EXAMINATION, HE HAD EYEBAGS, DERMATOCHALASIS AND BLEPHAROPTOSIS. THE PATIENTS MEDICAL HISTORY INCLUDED 3 DOSES OF COVID-19 VACCINATION WITH ASTRA ZENECA, DERMATOCHALASIS AND BLEPHAROPTOSIS. IN (B)(6) 2022, AFTER THE TREATMENT WITH BELOTERO BALANCE LIDOCAINE, THE PATIENT EXPERIENCED FACIAL SWELLING. ON (B)(6) 2023, 5 DAYS AFTER THE TREATMENT, HIS PARTNER CALLED AND REPORTED THAT THE FACIAL SWELLING STARTED 2-3 DAYS PRIOR, IT WAS GETTING WORSE AND THE PATIENT HAD DIFFICULTY BREATHING. HE IMMEDIATELY WENT TO THE EMERGENCY AND RECEIVED INTRAVENOUS HYDROCORT AND PIRITON. HE WAS HOSPITALIZED FOR OBSERVATION FOR 2 DAYS AND DISCHARGED WELL. HE HAD AN ANGIOEDEMA. AS REPORTED, AFTER THAT THE FILLERS WENT WITHOUT ANY HYALASE INVOLVED. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF THE EVENTS WAS CONSIDERED AS RESOLVING. FOLLOW-UP INFORMATION WAS RECEIVED ON 05-JUL-2023: THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR BELOTERO BALANCE LIDOCAINE WAS CONFIRMED AS 326125/1 (EXPIRY DATE: 10/2023).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2030097 BELOTERO BALANCE LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A 326125/1

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization BELOTERO VOLUME LIDOCAINE