BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEOSYAL RHA 3

    MDR report key: 7226999 · Received January 30, 2018

    Report

    Report Number
    3005975625-2017-00004
    Event Type
    Injury
    Date Received
    January 30, 2018
    Date of Event
    November 9, 2017
    Report Date
    January 11, 2018
    Manufacturer
    TEOXANE S.A.
    Product Code
    LMH
    PMA / PMN Number
    P170002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ATTENTION: THIS MDR WAS ALSO SENT TO THE FDA VIA (B)(4) ON 01/11/2018 BECAUSE OF THE ABSENCE OF PRODUCTION WEBTRADER ACCOUNT AT THIS DATE. SKIN NECROSIS 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. LITERATURE DATA: DELORENZI C. COMPLICATIONS OF INJECTABLE FILLERS, PART 2: VASCULAR COMPLICATIONS. AESTHET 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. MANAFI A, BARIKBIN B, MANAFI A, HAMEDI ZS, MOGHADAM SA. NASAL ALAR NECROSIS FOLLOWING HYALURONIC ACID INJECTION INTO NASOLABIAL FOLDS: A CASE REPORT. WORLD JOURNAL OF PLASTIC SURGERY. 2015;4(1).

    Description of Event or Problem · 1

    THIS EVENT TOOK PLACE OUTSIDE THE U.S., IN (B)(6). ON 12/14/2017, TEOXANE WAS INFORMED OF AN EVENT THAT OCCURRED IN (B)(6) FOLLOWING THE INJECTION OF 0.4ML OF TEOSYAL RHA 3 IN THE NOSE TIP AND NOSE BRIDGE. THE INITIAL REPORTER INDICATED THAT THE PATIENT PRESENTED WITH MODERATE INFLAMMATION THE SAME DAY AS THE INJECTION DAY. THIS INFORMATION WAS RECEIVED BY TEOXANE FORM THE DISTRIBUTOR IN (B)(4) MORE THAN ONE MONTH AFTER ITS OCCURRENCE. THE INITIAL REPORTER INDICATES THAT THE TREATMENTS LISTED BELOW WERE PRESCRIBED TO TREAT THE REACTION. HOWEVER, UPON THE REPORTS INDICATES THAT 1 MONTH AFTER THE OCCURRENCE OF THE EVENT, THE SITUATION HAD ONLY PARTIALLY IMPROVED. TREATMENT PRESCRIBED BY THE INITIAL REPORTER: OZONOTHERAPY ON (B)(6) 2017 (2 SESSIONS OVER 2 DAYS); ORAL STEROIDS, 30MG ON (B)(6) 2017 (1 DAY); LOCAL STEROIDS ON (B)(6) 2017 (1 DAY). LATER THE SAME DAY, TEOXANE RECEIVED SOME PHOTOS OF THE REACTION. A CLINICAL ASSESSMENT WAS PERFORMED INTERNALLY AND CONCLUDED THAT THE REACTION COULD BE A VASCULAR COMPLICATION FOLLOWING THE ACCIDENTAL INJECTION OF THE PRODUCT INSIDE OR CLOSE TO A BLOOD VESSEL. THE PHOTOS WERE PASSED ON TO A MEDICAL EXPERT WHO CONCURRED TO THE SAME CONCLUSION. CONSIDERING THE DELAY BETWEEN THE OCCURRENCE OF THE EVENT AND THE RECEPTION OF THE INFORMATION BY TEOXANE, THE MEDICAL EXPERT INDICATED THAT IT WAS CERTAINLY TOO LATE TO INITIATE USUAL TREATMENTS FOR VASCULAR OCCLUSION BY DERMAL FILLER. MORE RECENT PHOTOS (DATE UNSPECIFIED) WERE RECEIVED ON 12/15/2017 AND WERE SHOWING AN ADVANCED STAGE OF MODERATE SKIN NECROSIS HEALING. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE INITIAL REPORTER REGARDING THE PATIENT'S RECOVERY AFTER THE 12/15/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71585 TEOSYAL RHA 3 HYALURONIC ACID DERMAL FILLER GEL LMH TEOXANE S.A. NOT APPLICABLE TP27L-171114A

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other