BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 3

    MDR report key: 8463682 · Received March 29, 2019

    Report

    Report Number
    3005975625-2019-00009
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    March 4, 2019
    Report Date
    March 29, 2019
    Manufacturer
    TEOXANE SA
    Product Code
    LMH
    PMA / PMN Number
    170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EDEMA, REDNESS AND SWELLING ARE WELL KNOWN AND DESCRIBED ADVERSE REACTIONS FOLLOWING HYALURONIC ACID BASED DERMAL FILLER INJECTIONS. THE CAUSE CAN BE VARIOUS AND THE ONSET OF THE SIDE EFFECTS CAN BE DELAYED. THEY ARE USUALLY TREATED ADEQUATELY WITH NO SEQUELAE. THE RISK OF SUCH ADVERSE REACTIONS IS MENTIONED IN THE PRODUCT LABELLING. MOREOVER, THE PATIENT HAS BEEN DOING A LOT OF SUNBATHING, WHICH IS ALSO KNOWN AS BEING A POSSIBLE ONSETTING FACTOR FOR SUCH A REACTION. THIS ASSESSMENT HAS ALSO BEEN CONFIRMED BY THE MEDICAL EXPERT. WHO CONCLUDED THAT THERE WAS SOME SORT OF INFLAMMATORY PROCESS GOING ON. PROBABLY THIS CAUSED RHINITIS, THAT IN TURN CAUSED THE MULTIPLE SNEEZE AND LOCAL OEDEMA. SHE DID NOT PERSONALLY VISIT THE PATIENT BUT SHE IS FAIRLY CERTAIN THAT THE FILLER WAS NOT THE TRIGGER. IN HER OPINION SHE THINKS THAT INSTEAD THE FILLER MIGHT HAVE OBSTRUCTED LOCAL OEDEMA REABSORPTION. LITERATURE DATA: DE BOULLE K, HEYDENRYCH I. "PATIENT FACTORS INFLUENCING DERMAL FILLER COMPLICATIONS: PREVENTION, ASSESSMENT, AND TREATMENT." CLIN COSMET INVESTIG DERMATOL. 2015; 8: 205-14. KADOUCH JA, KADOUCH DJ, FORTUIN S, ET AL. "DELAYED-ONSET COMPLICATIONS OF FACIAL SOFT TISSUE AUGMENTATION WITH PERMANENT FILLERS IN 85 PATIENTS." DERMATOL SURG 2013; 39 (10): 1474-85. 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. LEE, J. M. AND Y. J. KIM (2015). "FOREIGN BODY GRANULOMAS AFTER THE USE OF DERMAL FILLERS: PATHOPHYSIOLOGY, CLINICAL APPEARANCE, HISTOLOGIC FEATURES, AND TREATMENT." ARCH PLAST SURG 42 (2): 232-239.

    Description of Event or Problem · 1

    THE DESCRIBED EVENT HAPPENED OUTSIDE THE U.S., IN (B)(6). ACCORDING TO THE INFORMATION RECEIVED, APPROXIMATELY 11 MONTHS AFTER SEVERAL INJECTIONS IN THE MALAR AREA AND THE CHEEKBONES, THE PATIENT PRESENTED WITH A DELAYED ADVERSE REACTION. THE PATIENT RECEIVED SEVERAL INJECTIONS: ON (B)(6) 2018, SHE WAS TREATED WITH PROFHILO FOR BIOREVITALIZATION ((B)(4)). ON (B)(6) 2018, SHE RECEIVED 1.2 ML OF TEOSYAL PURESENSE ULTRA DEEP IN EACH SIDE OF THE FACE IN THE CHEEKBONES AND MALAR AREA. ON (B)(6) 2018, SHE WAS TREATED WITH TEOSYAL RHA 3 IN THE MALAR AREA (THE PURPOSE OF THIS REPORT) AND AGAIN WITH PROFHILO. ON (B)(6) 2018, SHE WAS TREATED AGAIN WITH PROFHILO. IN (B)(6) 2019, THE PATIENT PRESENTED WITH REDNESS IN THE TEAR THROUGH AREA, WHICH DEVELOPED INTO AN OEDEMA IN THE LEFT TEAR THROUGH AREA (REPORTED ON (B)(6) 2019). ON (B)(6) 2019, THE OEDEMA WORSENED, AND ON THE FOLLOWING DAY, THE PATIENT PRESENTED WITH A SWELLING OF THE LEFT SIDE OF THE NOSE. PATIENT STARTED ALSO TO COMPLAIN HOMOLATERAL ITCHING IN THE INTERNAL CANTHUS OF THE EYE ON (B)(6) 2019. ON (B)(6) 2019, SHE COMPLAINED A LOCALIZED SWELLING IN THE LEFT TEAR TROUGH AREA. THE PATIENT DECIDED TO GO TO THE EMERGENCY CENTER FOR EYE EXAMINATION ON (B)(6) 2019 AFTER A SEVERE SEQUENCE OF SNEEZE (10-15 SIMULTANEOUSLY) THAT CAUSED HER THE IMPOSSIBILITY TO BREATH FROM THE LEFT NOSTRIL. THE REPORT OF THE E.R SAID "BLEPHARITIS" AND TREATMENT INITIATED INCLUDES A CORTISONIC CREAM FOLLOWING THE EMERGENCY CONSULTATION. THE INFORMATION RECEIVED IS LIKELY TO INDICATE A MODERATE TO SEVERE OEDEMA WITH SWELLING AND COMPLICATIONS IN REGARDS TO THE UPPER AIRWAYS. A MEDICAL EXPERT HAS BEEN CONTACTED IN ORDER TO ASSIST THE PRACTITIONER REGARDING THE RESOLUTION OF THE ADVERSE EVENTS AND TO IDENTIFY A ROOT CAUSE. ACCORDING TO THE FACT THAT THE PATIENT HAS BEEN DOING A LOT OF SUNBATHING, THE EXPERT CAME TO THE CONCLUSION THAT THERE WAS SOME SORT OF INFLAMMATORY PROCESS GOING ON. PROBABLY THIS CAUSED RHINITIS, THAT IN TURN CAUSED THE MULTIPLE SNEEZE AND LOCAL OEDEMA. SHE DID NOT PERSONALLY VISIT THE PATIENT BUT SHE IS FAIRLY CERTAIN THAT THE FILLER WAS NOT THE TRIGGER. IN HER OPINION SHE THINKS THAT INSTEAD THE FILLER MIGHT HAVE OBSTRUCTED LOCAL OEDEMA REABSORPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257918 TEOSYAL RHA 3 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE SA NOT APPLICABLE TP27L-174811B

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other