BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 4

    MDR report key: 12007266 · Received June 16, 2021

    Report

    Report Number
    3005975625-2021-00222
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    May 14, 2021
    Report Date
    July 9, 2021
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VASCULAR COMPLICATIONS 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 · 0

    ACCORDING TO THE RECEIVED INFORMATION, THE PATIENT WAS INJECTED ON (B)(6) 2021 IN THE CHIN AREA WITH A RHA 2 PRODUCT , A RHA 3 PRODUCT AND A RHA 4 PRODUCT .2 LINKED COMPLAINTS HAVE BEEN OPENED REGARDING THE INJECTION OF RHA 2 (RC/2105070) AND RHA 3 (RC/2105072). UPON RETURNING FROM LUNCH THE PATIENT NOTICED HER LEFT CHIN WAS BRUISED AND COMPLAINED A LOT OF PAIN. THE INJECTOR NOTICED A WHITE HALO AROUND THE BRUISED AREA THAT DEVELOPED 2 HOURS AFTER THE INJECTION AND DIAGNOSED SIGNS OF VASCULAR OCCLUSION . LATER THAT NIGHT, SHE INJECTED HYALURONIDASE AND PATIENT REPORTED THAT THE PAIN WAS GONE. SUBSEQUENTLY, THE BRUISE TURNED FROM A DEEP PURPLE/BLACK TO LIGHTER RED. ON (B)(6) 2021, THE PATIENT RECEIVED 2 VIALS OF HYALURONIDASE AS TREATMENT AS WELL AS LASERING TO THE BRUISE IN ORDER TO DISSOLVE THE AREAS IN THE LOWER FACE. ON (B)(6) 2021, THE INJECTOR REPORTED THAT THE OCCLUSION HAS COMPLETELY RESOLVED FUP 09.07.2021 : THE BATCH NUMBER INJECTED HAS BEEN RETRIEVED : TPUL-205017A.

    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 ON (B)(6) 2021 IN THE CHIN AREA WITH A RHA 2 PRODUCT , A RHA 3 PRODUCT AND A RHA 4 PRODUCT .2 LINKED COMPLAINTS HAVE BEEN OPENED REGARDING THE INJECTION OF RHA 2 (RC/(B)(4)) AND RHA 3 (RC/(B)(4)). UPON RETURNING FROM LUNCH THE PATIENT NOTICED HER LEFT CHIN WAS BRUISED AND COMPLAINED A LOT OF PAIN. THE INJECTOR NOTICED A WHITE HALO AROUND THE BRUISED AREA THAHT DEVELOPED 2 HOURS AFFTER THE INJECTION AND DIAGNOSED SIGNS OF VASCULAR OCCLUSION . LATER THAT NIGHT, SHE INJECTED HYALURONIDASE AND PATIENT REPORTED THAT THE PAIN WAS GONE. SUBSEQUENTLY, THE BRUISE TURNED FROM A DEEP PURPLE/BLACK TO LIGHTER RED. ON (B)(6) THE PATIENT RECEIVED 2 VIALS OF HYALURONIDASE AS TREATMENT AS WELL AS LASERING TO THE BRUISE IN ORDER TO DISSOLVE THE AREAS IN THE LOWER FACE. ON (B)(6) THE INJECTOR REPORTED THAT THE OCCLUSION HAS COMPLETELY RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909338 TEOSYAL RHA 4 HYALURONIC ACID DERMALL FILLER GEL LMH TEOXANE SA TPUL-205017A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other