BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELOTERO BALANCE LIDOCAINE

    MDR report key: 11920657 · Received June 2, 2021

    Report

    Report Number
    3013840437-2021-00140
    Event Type
    Injury
    Date Received
    June 2, 2021
    Report Date
    June 2, 2021
    Manufacturer
    ANTEIS S.A.
    Product Code
    LMH
    PMA / PMN Number
    P090016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, ITCHING / RASH (PT: RASH PRURITIC) 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 PROVIDED.

    Description of Event or Problem · 1

    THIS MDR IS RELATED TO MDR 3013840437-2021-00125 REFERRING TO THE SAME PATIENT. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A FEMALE PATIENT. SHE WAS INJECTED WITH BELOTERO® BALANCE LIDOCAINE, INTO THE TEAR TROUGHS (OFF LABEL USE OF DEVICE). AFTER THE TREATMENT WITH BELOTERO® BALANCE LIDOCAINE, THE PATIENT EXPERIENCED A GENERALIZED REACTION WITH SWELLING AND ITCHING, ON HER ARM AND ALL OVER. THE PATIENT WENT TO THE EMERGENCY ROOM. SHE RECEIVED STEROIDS AND BENADRYL WITH NO SIGNIFICANT RESPONSE. AFTER A HIGH DOSE OF STEROIDS, THE PATIENT STARTED RESPONDING, AND AFTER 2 DAYS, THE RASH WAS RESOLVING. THE OUTCOME OF THE EVENT ITCHING/ RASH WAS REPORTED AS RESOLVING. THE OUTCOME OF THE EVENT SWELLING WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817468 BELOTERO BALANCE LIDOCAINE IMPLANT, DERMAL, FOR AESTHETIC USE LMH ANTEIS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention