BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 4

    MDR report key: 7226996 · Received January 30, 2018

    Report

    Report Number
    3005975625-2017-00001
    Event Type
    Injury
    Date Received
    January 30, 2018
    Date of Event
    September 23, 2017
    Report Date
    May 1, 2018
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT TEOSYAL RHA 4 HAS BEEN INJECTED AT THE SAME SITE AS OTHER PRODUCTS WITH WHICH THE POSSIBLE INTERACTION HAVE NEVER BEEN CLINICALLY TESTED. FOR THIS REASON, THE PRODUCT'S INSTRUCTIONS FOR USE STATE IN THE CONTRAINDICATIONS SECTION THAT IT SHOULD NOT BE INJECTED AT THE SAME SITE AS ANOTHER DERMAL FILLER. GRANULOMAS AND ABSCESSES ARE WELL KNOWN AND DOCUMENTED ADVERSE REACTIONS AS PART OF DERMAL FILLERS INJECTIONS. GRANULOMAS ARE USUALLY RELATED TO A REACTION OF THE IMMUNE SYSTEM AGAINST A FOREIGN BODY CONSTITUTED BY THE IMPLANT. ABSCESSES ARE USUALLY RELATED TO THE ACCIDENTAL INTRODUCTION OF A BACTERIAL GERM DURING OR IMMEDIATELY AFTER AN INJECTION. PLEASE REFER TO BIBLIOGRAPHIC REFERENCES BELOW. IN THE PRESENT CASE, WE ARE UNABLE TO DETERMINE WHETHER THE GRANULOMATOUS REACTION WAS CAUSED BY THE TEOSYAL PRODUCT OR THE ALIAXIN PRODUCT. THERE ARE 3 POSSIBILITIES: THE GRANULOMAS ARE RELATED TO THE ALIAXIN PRODUCT AND THE TEOSYAL PRODUCT INJECTION TRIGGERED THE REACTION; THE GRANULOMAS ARE RELATED TO THE TEOSYAL PRODUCT; THE GRANULOMAS ARE RELATED TO BOTH PRODUCT. AT THIS STAGE, AND AS PER THE AVAILABLE INFORMATION, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE INCIDENT. LITERATURE DATA: BELEZNAY K, CARRUTHERS JD, CARRUTHERS A, ET AL. DELAYED-ONSET NODULES SECONDARY TO A SMOOTH COHESIVE 20 MG/ML HYALURONIC ACID FILLER: CAUSE AND MANAGEMENT. DERMATOL SURG 2015;41(8):929-39 HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/26166260 SIGNORINI, M., ET AL. (2016). "GLOBAL AESTHETICS CONSENSUS: AVOIDANCE AND MANAGEMENT OF COMPLICATIONS FROM HYALURONIC ACID FILLERS-EVIDENCE- AND OPINION-BASED REVIEW AND CONSENSUS RECOMMENDATIONS." PLASTIC AND RECONSTRUCTIVE SURGERY 137(6): 961E-971E HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/27219265 DE BOULLE K, HEYDENRYCH I. PATIENT FACTORS INFLUENCING DERMAL FILLER COMPLICATIONS: PREVENTION, ASSESSMENT, AND TREATMENT. CLIN COSMET INVESTIG DERMATOL. 2015;8:205-14 HTTP://WWW.NCBI.NLM.NIH.GOV/PUBMED/25926750 PLEASE NOTE THAT THIS MDR WAS SENT TO THE CDRH BY FEDEX ON (B)(6) 2018. THE REASON FOR NOT SUBMITTING IT ELECTRONICALLY IS THAT TEOXANE'S WEBTRADER PRODUCTION ACCOUNT FOR ESUBMISSIONS WAS NOT AVAILABLE AT THIS TIME. THANK YOU FOR YOUR COMPREHENSION.

    Description of Event or Problem · 1

    THIS EVENT TOOK PLACE OUTSIDE THE U.S., IN (B)(6). THE INITIAL REPORTER (INJECTOR) INDICATES THAT ABOUT 2 WEEKS AFTER THE INJECTION OF 1ML OF THE PRODUCT IN THE NASOLABIAL FOLDS (0.6ML), THE MARIONNETTE LINES (0.2ML) AND THE GLABELLA (0.2ML), THE PATIENT PRESENTED WITH AN ADVERSE REACTION IN THE RIGHT NASOLABIAL FOLD. THE SAME ADVERSE REACTION OCCURRED IN THE RIGHT MARIONNETTE LINE 1.5 MONTH AFTER THE INJECTION. IT THEN OCCURRED IN THE GLABELLA, THE LEFT NASOLABIAL FOLD AND MARIONNETTE LINE 2 MONTHS AFTER THE INJECTION. DETAILED CHRONOLOGY OF THE EVENTS IS PRESENTED BELOW: ON (B)(6) 2017: SUBCUTANEOUS NODULE WITH PUSTULE IN THE RIGHT NASOLABIAL FOLD, ON (B)(6) 2017: SUBCUTANEOUS NODULE IN THE RIGHT MARIONNETTE LINE, ON (B)(6) 2017: SUBCUTANEOUS NODULE IN LEFT MARIONNETTE LINE, LEFT NASOLABIAL FOLD AND GLABELLA, ON (B)(6) 2017: EXTERNAL EXPERT ADVICE SUGGESTED IT WAS STERILE ABSCESSES AND SHOULD BE DRAINED, ON (B)(6) 2017: SUBCUTANEOUS NODULES ON THE RIGHT SIDE HAVE WORSENED AND TURNED TO INFLAMMED NODULES > NEW ASSESSMENT OF THE ADVERSE REACTION AND DECISION TO REPORT THE INCIDENT TO THE ITALIAN MOH. HOWEVER THE NODULES ARE TOTALLY RESOLVED ON THE LEFT SIDE. ACCORDING TO AN EXTERNAL EXPERT ADVICE, THE REACTION ON THE RIGHT SIDE IS LIKELY TO BE GRANULOMATOUS FORMATIONS, WITH POSSIBLE ABSCESSES FORMATION. THE ABSCESSES MIGHT BE RELATED TO A CONTAMINATION THROUGH THE HYALURONIDASE INJECTIONS. THE FOLLOWING TREATMENTS WERE PRESCRIBED/ADMINISTERED: (B)(6) 2017: ANTIBIOTICS PER OS, (B)(6) 2017: STEROIDS PER OS, (B)(6) 2017: ANTIBIOTIC INTRAMUSCULAR, (B)(6) 2017: ANTIBIOTIC PER OS + STEROIDS PER OS, (B)(6) 2017: ANTIBIOTIC PER OS, (B)(6) 2017: (AFTER THE 21ST): DRAINAGE OF THE STERILE ABSCESSES AND HYALURONIDASE INJECTIONS > RESOLUTION ON THE LEFT SIDE BUT WORSENING ON THE RIGHT SIDE. NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTED SINCE (B)(6) 2017 ABOUT PATIENT'S STATE EVOLUTION AND TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71582 TEOSYAL RHA 4 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE S.A. NOT APPLICABLE TPUL-164415A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other