BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 3

    MDR report key: 7572477 · Received June 6, 2018

    Report

    Report Number
    3005975625-2018-00005
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    May 3, 2018
    Report Date
    May 16, 2018
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE PERFORMED A REVIEW OF THE BATCH RECORDS FOR THE CONCERNED LOT NUMBER, WHICH APPEARED TO BE WITHIN SPECIFICATIONS, MEANING NO DEFAULTS HAD BEEN HIGHLIGHTED DURING PRODUCTION. 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. PLEASE REFER TO THE BIBLIOGRAPHY BELOW. LITERATURE DATA: DELORENZI C. COMPLICATIONS OF INJECTABLE FILLERS, PART 2: VASCULAR COMPLICATIONS. ANESTHET SURG J. 2014;34(4):584-600. FUNT D, PAVICIC T. DERMAL FILLERS IN AESTHETICS: AN OVERVIEW OF ADVERSE EVENTS AND TREATMENT APPROACHES. CLIN COSMET INVESTIG DERMATOL 2013;6:295-316.

    Description of Event or Problem · 1

    THIS EVENT TOOK PLACE OUTSIDE THE U.S., IN (B)(6). ACCORDING TO THE RECEIVED INFORMATION, THE PATIENT PRESENTED WITH AN ADVERSE REACTION IN THE FOREHEAD REGION, THE DAY FOLLOWING THE INJECTION. THE PATIENT PRESENTED WITH VASCULAR OCCLUSION, WHICH MANIFESTED IN A TRANSIENT ISCHEMIA THAT DIDN'T RESULTED IN NECROSIS. THE PATIENT WAS INJECTED ON (B)(6) 2018 AND THE REACTION OCCURED THE DAY AFTER. THE PATIENT WAS TREATED WITH PRESCRIPTIONS OF ANTIBIOTICS. THE PHYSICIAN INDICATED THAT SHE WAS RECOVERING PARTIALLY AT THE TIME OF THIS DECLARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416703 TEOSYAL RHA 3 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE S.A. NOT APPLICABLE TP27L-180315A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other