BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 2

    MDR report key: 7572474 · Received June 6, 2018

    Report

    Report Number
    3005975625-2018-00008
    Event Type
    Injury
    Date Received
    June 6, 2018
    Date of Event
    May 4, 2018
    Report Date
    May 17, 2018
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL ANALYSIS OF THE RELATED BATCHES WAS CARRIED OUT TO TEST FOR SPECIFICATION AND STERILITY COMPLIANCE. THE ANALYSIS RESULTS SHOWED FULL COMPLIANCE TO FINISHED PRODUCT SPECIFICATIONS AND STERILITY OF THE BATCH IN QUESTION. PLEASE NOTE THAT WE COULD NOT RE-CHECK THE STERILITY OF THE RELATED PRODUCT, DUE TO THE FACT THAT THE SYRINGE HAD BEEN DISCARDED AFTER USE. CLINICAL ASSESSMENT REVEALED THAT LUMPS ARE WELL KNOWN AND DOCUMENTED ADVERSE REACTIONS TO DERMAL FILLER IMPLANTS. THEY CAN BE THE RESULT OF GEL MIGRATION, WHICH APPEARS WHEN THE GEL WAS INJECTED WITH A LARGER DEPOSIT IN ONE AREA (OVERCORRECTION), OR CAN UNDERLINE A LOCALIZED INFECTION. IT USUALLY RESOLVES WITHIN A COUPLE OF WEEKS. AS PART OF THIS CUSTOMER COMPLAINT, A MEDICAL ADVICE WAS ASKED TO A HEALTH PROFESSIONAL, WHICH CONFIRMS THE LATE REACTION WHICH MAY BE DUE TO THE PRODUCT INJECTED, AND THE POSSIBILITY OF AN INFECTION. A REVIEW OF THE IFUS INDICATED SIDE EFFECTS, AND PROVIDED INSTRUCTIONS REGARDING REPORTING SECONDARY EFFECTS. BIBLIOGRAPHY: DE BOULLE K, HEYDENRYCH I. PATIENT FACTORS INFLUENCING DERMAL FILLER COMPLICATIONS: PREVENTION, ASSESSMENT, AND TREATMENT. CLIN COSMET INVESTIG DERMATOL. 2015;8:205-14. FUNT D, PAVICIC T. DERMAL FILLERS IN AESTHETICS: AN OVERVIEW OF ADVERSE EVENTS AND TREATMENT APPROACHES. CLIN COSMET INVESTIG DERMATOL 2013;6:295-316. - WOODWARD, J., ET AL. (2015). "FACIAL FILLER COMPLICATIONS." FACIAL PLASTIC SURGERY CLINICS OF NORTH AMERICA 23(4): 447-458. DELORENZI, C. (2013). "COMPLICATIONS OF INJECTABLE FILLERS, PART I." AESTHET SURG J 33(4): 561-575.

    Description of Event or Problem · 1

    THE EVENT TOOK PLACE OUTSIDE THE U.S., IN (B)(6). ACCORDING TO THE RECEIVED INFORMATION, THE PATIENT PRESENTED WITH AN ADVERSE REACTION IN THE LOWER FACE REGION (MARIONETTE LINES), 5 MONTHS AFTER THE INJECTION. THE PATIENT PRESENTED WITH NODULES AND INDURATION IN THE MARIONETTE LINES AREA, WITH A LOSS OF SENSIBILITY. THE PATIENT WAS INJECTED ON (B)(6) 2017 IN THE MARIONETTE LINES AND THE LIPS, AND A SECOND SESSION WAS INITIATED ON (B)(6) 2018, ALSO IN THE MARIONETTE LINES AREA. THIS REPORT CONCERNS A PRODUCT INJECTED ON THE (B)(6) 2018 SESSION. THE PATIENT WAS TREATED WITH HYALURONIDASE. THE PHYSICIAN INDICATED THAT THERE WERE NO RECOVERY AT THE TIME OF THIS DECLARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416466 TEOSYAL RHA 2 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE S.A. NOT APPLICABLE TP30L-173613A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other