BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 2

    MDR report key: 11567592 · Received March 25, 2021

    Report

    Report Number
    3005975625-2021-00050
    Event Type
    Injury
    Date Received
    March 25, 2021
    Date of Event
    February 18, 2021
    Report Date
    March 25, 2021
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VASCULAR COMPLICATIONS (OCCLUSIONS) ARE WELL KNOWN AND DOCUMENTED ADVERSE REACTIONS AS PART OF HYALURONIC ACID-BASED DERMAL FILLERS INJECTIONS. THEY ARE RELATED TO THE ACCIDENTAL INJECTION OF THE PRODUCT INSIDE OR CLOSE TO A BLOOD VESSEL LEADING TO AN OCCLUSION OR A COMPRESSION AND BLOCKING THE BLOOD FLOW, GENERALLY REFERED TO AS VASCULAR COMPLICATION. IF THE VASCULAR COMPLICATION IS NOT DETECTED/DIAGNOSED AND TREATED TIMELY, IT CAN LEAD TO A SKIN NECROSIS. THE RISK OF VASCULAR COMPLICATION AND SKIN NECROSIS ARE MENTIONED IN THE PRODUCT LABELLING.

    Description of Event or Problem · 1

    ACCORDING TO THE RECEIVED INFORMATION THE PATIENT WAS INJECTED WITH 1 SYRINGE OF RHA2 IN THE RIGHT UPPER LIP. THE TECHNIQUE USED FOR ADMINISTRATION OF RHA2 WAS UNKNOWN. IT WAS CONTINUED IN ADDITIONAL INFO SECTION ADMINISTRATION. ON (B)(6) 2021, 24 HOURS POST INJECTION, THE PATIENT DEVELOPED SYMPTOMS OF "SIGNIFICANT" HERPETIC INFECTION WITH PAIN AND LIPS BEGAN BRUISE AND LOOK DARK AND DUSTY, AND NO SWELLING. THE PATIENT EXPERIENCED A VASCULAR OCCLUSION/COMPRESSION IN A SMALL BRANCH OF THE SUPERIOR LABIAL ARTERY. THE PATIENT DID NOT HAVE ANY PAIN FROM THE OCCLUSION. TREATMENT INCLUDED VALTREX, ASPIRIN, AND A WARM COMPRESS. TWO DAYS LATER, THE AREA HAD NOT LIGHTENED UP AND STILL LOOKED MOTTLED. THEN IT WAS DECIDED TO DISSOLVE THE FILLER WITH 200 UNITS OF 200 UNITS AND SALINE TO THE RIGHT UPPER LIP. AFTER DISSOLVING THE FILLER, THE AREA IMPROVED SIGNIFICANTLY AND NOW THE PATIENT HAD A FAINT "PURPLE HUE." THE OUTCOME OF THE EVENTS WAS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466140 TEOSYAL RHA 2 HYALURONIC ACID DERMALL FILLER GEL LMH TEOXANE SA TP30L-202514A

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other